Trial record 1 of 1 for:
NCT03412201
Safety, Tolerability and Efficacy of Rapid Optimization, Helped by NT-proBNP testinG, of Heart Failure Therapies (STRONG-HF)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03412201 |
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Recruitment Status : Unknown
Verified February 2021 by Heart Initiative.
Recruitment status was: Recruiting
First Posted : January 26, 2018
Last Update Posted : February 12, 2021
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Sponsor:
Heart Initiative
Collaborators:
Hôpitaux Universitaires Saint-Louis-Lariboisière
Momentum Research, Inc.
Roche Diagnostics
Inserm UMRS 942
Information provided by (Responsible Party):
Heart Initiative
- Study Details
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Brief Summary:
STRONG-HF is a multicenter, randomized, parallel group study designed to evaluate the efficacy and safety of up-titration of standard oral heart failure medications during hospitalization for acute heart failure. Patients admitted for acute heart failure will be randomized within 2 days before discharge to either usual care or intensification of treatment with a beta-blocker, a renin-angiotensin system blocker, and a mineralocorticoid receptor blocker ("high intensity care" arm). In the "high intensity care" arm, patients' clinical signs and symptoms of heart failure will be assessed, and routine laboratory measures and biomarkers will be measured, at frequent post-discharge visits. When these measures indicate that it is safe to do so, the doses of the oral heart failure medications will be increased to optimal levels. Patients will be followed through 180 days from randomization. Patients assigned to the usual care group will be followed by their general physician and/or cardiologist according to local medical standards. Patients who were screened but did not meet eligibility criteria will be followed for 90-day outcome. Randomized patients will be contacted at 180 days to assess outcomes.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Heart Failure | Other: Usual Care Other: High Intensity Care | Not Applicable |
STRONG-HF is a multicenter, randomized, parallel group study designed to evaluate the efficacy and safety of up-titration of standard of care medical therapy including beta-blockers; angiotensin converting enzyme inhibitors (ACEi), angiotensin receptor blocker (ARB) or angiotensin receptor neprolysin inhibitor (ARNi); and mineralocorticoid receptor antagonist (MRAs), on morbidity and mortality when initiated and up-titrated early during hospitalization for acute heart failure (AHF). Optimal safety conditions will allow physicians to introduce and/or continue oral HF therapies during this "vulnerable phase" in AHF patients. Patients admitted for AHF with clinical signs of congestion and elevated circulating N-terminal pro-B-type natriuretic peptide (NT-proBNP) and who are not treated with optimal doses of oral heart failure (HF) therapies within 2 days before hospital discharge for AHF and who are hemodynamically stable will be randomized in a 1:1 ratio to either usual care (named "usual care" arm) or intensification of treatment with beta-blockers, and ACEi (or ARB) or ARNi and a MRA (named "high intensity care" arm). In the latter arm, repeated assessments of clinical signs and symptoms of heart failure, routine clinical laboratory measures including potassium, sodium, and creatinine as well as NT-ProBNP will foster, encourage and ensure the safety of the optimization of oral heart failure therapies. AHF patients who were screened but did not meet inclusion criteria, including low circulating NT-proBNP at visit 2, will be followed for 90-day outcome. Randomized patients will be contacted at 180 days to assess outcomes.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1800 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | multicenter, randomized, parallel group study |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Safety, Tolerability and Efficacy of Rapid Optimization, Helped by NT-proBNP testinG, of Heart Failure Therapies |
| Actual Study Start Date : | May 11, 2018 |
| Estimated Primary Completion Date : | October 2021 |
| Estimated Study Completion Date : | October 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Heart Failure
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Usual Care
Follow-up and management of heart failure medications provided by the patient's general physician and/or cardiologist according to local medical standards
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Other: Usual Care
Follow-up and management of heart failure medications provided by the patient's general physician and/or cardiologist according to local medical standards |
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Experimental: High Intensity Care
Follow-up and management of heart failure medications provided by specialists at participating institutions. Doses of oral heart failure medications optimized within 2 weeks, provided clinical assessments and laboratory measures indicate that it is safe to increase doses.
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Other: High Intensity Care
Follow-up and management of heart failure medications provided by specialists at participating institutions. Doses of oral heart failure medications optimized within 2 weeks, provided clinical assessments and laboratory measures indicate that it is safe to increase doses. |
Primary Outcome Measures :
- 180-day all-cause mortality or heart failure readmission [ Time Frame: 180 days ]Cumulative risk of either readmission for heart failure or death at 180 days
Secondary Outcome Measures :
- Change in quality of life [ Time Frame: 90 days ]Change from baseline to 90 days in quality of life as measured using the EQ-5D visual analogue scale (VAS) which ranges from 0 to 100 with a higher score representing a better outcome. "EQ-5D" is the official name of a quality of life instrument developed by EuroQol.
- 180-day all-cause mortality [ Time Frame: 180 days ]Cumulative risk of death at 180 days
- 90-day all-cause mortality or heart failure readmission [ Time Frame: 90 days ]Cumulative risk of either readmission for heart failure or death at 90 days
Other Outcome Measures:
- 180-day cardiovascular death [ Time Frame: 180 days ]Cumulative risk of death due to cardiovascular cause at 180 days
- 90-day cardiovascular death [ Time Frame: 90 days ]Cumulative risk of death due to cardiovascular cause at 90 days
- 90-day all-cause mortality [ Time Frame: 90 days ]Cumulative risk of death at 90 days
- 180-day heart failure readmission [ Time Frame: 180 days ]Cumulative risk of readmission for heart failure at 180 days
- 90-day heart failure readmission [ Time Frame: 90 days ]Cumulative risk of readmission for heart failure at 90 days
- Finkelstein-Schoenfeld hierarchical composite [ Time Frame: 90 days ]Hierarchical composite endpoint comprising death, heart failure readmissions, and EQ-VAS analyzed using Finkelstein-Schoenfeld methodology
- Change in NT-proBNP [ Time Frame: 90 days ]Change from baseline to 90 days in NT-proBNP on the log scale
- Change in weight [ Time Frame: 90 days ]Change from baseline to 90 days in weight in kg
- Changes in signs and symptoms of congestion: NYHA class [ Time Frame: 90 days ]Changes from baseline to 90 days in New York Heart Association (NYHA) class which ranges from 1 to 4 with a higher class representing a worse outcome
- Changes in signs and symptoms of congestion: orthopnea [ Time Frame: 90 days ]Changes from baseline to 90 days in orthopnea rated on a scale from 0 to 3 with a higher score representing a worse outcome
- Changes in signs and symptoms of congestion: peripheral edema [ Time Frame: 90 days ]Changes from baseline to 90 days in peripheral edema rated on a scale from 0 to 3 with a higher score representing a worse outcome
- Changes in signs and symptoms of congestion: rales [ Time Frame: 90 days ]Changes from baseline to 90 days in rales rated on a scale from 0 to 3 with a higher score representing a worse outcome
- Changes in signs and symptoms of congestion: JVP [ Time Frame: 90 days ]Changes from baseline to 90 days in jugular venous pulse (JVP) rated on a scale from 1 to 4 with a higher score representing a worse outcome
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Hospital admission within the 72 hours prior to Screening for acute heart failure with dyspnea at rest and pulmonary congestion on chest X-ray, and other signs and/or symptoms of heart failure such as edema and/or positive rales on auscultation.
- All measures within 24 hours prior to Randomization of systolic blood pressure ≥ 100 mmHg, and of heart rate ≥ 60 bpm.
- All measures within 24 hours prior to Randomization of serum potassium ≤ 5.0 mEq/L (mmol/L).
- Biomarker criteria for persistent congestion:
- At Screening, NT-proBNP > 2,500 pg/mL.
- At the time of Randomization (within 2 days prior to discharge), NT-proBNP > 1,500 pg/mL (to ensure the persistence of congestion) that has decreased by more than 10% compared to Screening (to ensure the acuity of the index episode).
- At 1 week prior to admission, at Screening, and at Visit 2 (just prior to Randomization) either (a) <= ½ the optimal dose of ACEi/ARB/ARNi (see Table) prescribed, no beta-blocker prescribed, and <= ½ the optimal dose of MRA prescribed or (b) no ACEi/ARB/ARNi prescribed, <= ½ the optimal dose of beta-blocker prescribed, and <= ½ the optimal dose of MRA prescribed.
- Written informed consent to participate in the study.
Exclusion Criteria:
- Age < 18 or > 85 years.
- Clearly documented intolerance to high doses of beta-blockers.
- Clearly documented intolerance to high doses of renin-angiotensin system (RAS) blockers (both ACEi and ARB).
- Mechanical ventilation [not including continuous positive airway pressure (CPAP)/bilevel positive airway pressure (BIPAP)] in the 24 hours prior to Screening.
- Significant pulmonary disease contributing substantially to the patients' dyspnea such as forced expiratory volume during the 1st second (FEV1)< 1 liter or need for chronic systemic or nonsystemic steroid therapy, or any kind of primary right heart failure such as primary pulmonary hypertension or recurrent pulmonary embolism.
- Myocardial infarction, unstable angina or cardiac surgery within 3 months, or cardiac resynchronization therapy (CRT) device implantation within 3 months, or percutaneous transluminal coronary intervention (PTCI), within 1 month prior to Screening.
- Index Event (admission for AHF) triggered primarily by a correctable etiology such as significant arrhythmia (e.g., sustained ventricular tachycardia, or atrial fibrillation/flutter with sustained ventricular response >130 beats per minute, or bradycardia with sustained ventricular arrhythmia <45 beats per minute), infection, severe anemia, acute coronary syndrome, pulmonary embolism, exacerbation of chronic obstructive pulmonary disease (COPD), planned admission for device implantation or severe non-adherence leading to very significant fluid accumulation prior to admission and brisk diuresis after admission. Troponin elevations without other evidence of an acute coronary syndrome are not an exclusion.
- Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophic obstructive cardiomyopathy.
- History of heart transplant or on a transplant list, or using or planned to be implanted with a ventricular assist device.
- Sustained ventricular arrhythmia with syncopal episodes within the 3 months prior to screening that is untreated.
- Presence at Screening of any hemodynamically significant valvular stenosis or regurgitation, except mitral or tricuspid regurgitation secondary to left ventricular dilatation, or the presence of any hemodynamically significant obstructive lesion of the left ventricular outflow tract.
- Active infection at any time during the AHF hospitalization prior to Randomization based on abnormal temperature and elevated white blood cells (WBC) or need for intravenous antibiotics.
- Stroke or transient ischemic attack (TIA) within the 3 months prior to Screening.
- Primary liver disease considered to be life threatening.
- Renal disease or estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2 [as estimated by the simplified Modification of Diet in Renal Disease (MDRD) formula] at Screening or history of dialysis.
- Psychiatric or neurological disorder, cirrhosis, or active malignancy leading to a life expectancy < 6 months.
- Prior (defined as less than 30 days from screening) or current enrollment in a congestive heart failure (CHF) trial or participation in an investigational drug or device study within the 30 days prior to screening
- Discharge for the AHF hospitalization anticipated to be > 14 days from admission, or to a long-term care facility. Randomization must occur within 12 days following admission and within 2 days prior to anticipated discharge.
- Inability to comply with all study requirements, due to major co-morbidities, social or financial issues, or a history of noncompliance with medical regimens, that might compromise the patient's ability to understand and/or comply with the protocol instructions or follow-up procedures
- Pregnant or nursing (lactating) women.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03412201
Contacts
| Contact: Maria Novosadova, MD | +41614851250 | marianovosadova@momentum-research.com |
Locations
Show 78 study locations
Sponsors and Collaborators
Heart Initiative
Hôpitaux Universitaires Saint-Louis-Lariboisière
Momentum Research, Inc.
Roche Diagnostics
Inserm UMRS 942
Investigators
| Principal Investigator: | Alexandre Mebazaa, MD PhD FESC | Inserm UMRS 942; Hôpitaux Universitaires Saint-Louis-Lariboisière, University Paris Diderot |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Heart Initiative |
| ClinicalTrials.gov Identifier: | NCT03412201 |
| Other Study ID Numbers: |
CHF201701 |
| First Posted: | January 26, 2018 Key Record Dates |
| Last Update Posted: | February 12, 2021 |
| Last Verified: | February 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Heart Initiative:
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Disease management Medication therapy management Biomarkers |
Additional relevant MeSH terms:
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Heart Failure Heart Diseases Cardiovascular Diseases |