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Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF (VITALITY-HFpEF)

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ClinicalTrials.gov Identifier: NCT03547583
Recruitment Status : Completed
First Posted : June 6, 2018
Results First Posted : December 3, 2020
Last Update Posted : January 6, 2021
Sponsor:
Collaborators:
Merck Sharp & Dohme LLC
Canadian VIGOUR Centre
Duke Clinical Research Institute
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
The primary hypothesis in this trial is that the treatment with vericiguat 10 mg or 15 mg in patients with HFpEF improves the KCCQ PLS (Kansas City Cardiomyopathy Questionnaire Physical limitation score) compared to placebo after 24 weeks of treatment.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure With Preserved Ejection Fraction Drug: Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 789 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Parallel-group, Placebo-controlled, Double-blind, Multi-center Trial to Evaluate the Efficacy and Safety of the Oral sGC stImulator Vericiguat to Improve Physical Functioning in Activities of Daily Living in Patients With Heart Failure and Preserved Ejection Fraction (VITALITY-HFpEF)
Actual Study Start Date : June 15, 2018
Actual Primary Completion Date : October 15, 2019
Actual Study Completion Date : November 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Vericiguat

Arms and Interventions
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Arm Intervention/treatment
Experimental: Vericiguat up to 10 mg
Subjects will receive vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, with sham titration at week 6.
 Drug: Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets
Oral use. Vericiguat, which will be started at 2.5 mg at randomization and up-titrated to 5 mg at week 2, and to 10 mg at week 4, with sham titration or up-titration to 15 mg at week 6.
Experimental: Vericiguat up to 15 mg
Subjects will receive vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, and to 15 mg at week 6.
 Drug: Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets
Oral use. Vericiguat, which will be started at 2.5 mg at randomization and up-titrated to 5 mg at week 2, and to 10 mg at week 4, with sham titration or up-titration to 15 mg at week 6.
Placebo Comparator: Placebo
Subject will receive placebo for 24 weeks, once daily, starting sham up-titration at weeks 2, 4, and 6.
 Drug: Placebo
Placebo and sham up-titration at weeks 2, 4, and 6


Outcome Measures
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Primary Outcome Measures :
  1. Change in KCCQ Physical Limitation Score From Baseline to Week 24 [ Time Frame: From baseline to Week 24 ]
    The City Cardiomyopathy Questionnaire (KCCQ) measures the impact of patients' heart failure, or its treatment, on 6 domains; Physical Limitation, Symptom (with subscores for frequency and burden), Quality of Life, Social Limitations, Symptom Stability and Self-Efficacy. Scores are calculated by summing domain responses and then transforming scores to a 0-100 unit scale with higher scores indicating better health status.


Secondary Outcome Measures :
  1. Change in the Six-minute Walk Test (6MWT) From Baseline to Week 24 [ Time Frame: From baseline to Week 24 ]
    6MWT was conducted to test the physical limitations of the patient by assessing the patient's exercise capacity. The distance walked by the patient in 6 minutes was measured.


Other Outcome Measures:
  1. Number of Participants With Treatment Emergent Adverse Events [ Time Frame: From first application of study drug up to 5 calendar days after end of treatment with study drug ]
    An AE is any untoward medical occurrence (i.e. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a patient or clinical investigation patient after providing written informed consent for participation in the study. Adverse events are considered to be treatment-emergent if they have started or worsened after first application of study medication up to 5 calendar days after end of treatment with study medication.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previous diagnosis of chronic heart failure (HF)
  • HF decompensation within 6 months prior to randomization, defined as hospitalization for HF or intravenous (IV) diuretic treatment for HF without hospitalization.

  • N-terminal pro brain natriuretic peptide (NT-proBNP) ≥300 or brain natriuretic peptide (BNP) ≥100 pg/mL in sinus rhythm, or NT-proBNP

    ≥600 or BNP ≥200 pg/mL in atrial fibrillation within 30 days prior to randomization

  • Diagnostic criteria of HFpEF by echocardiography assessed within 12 months prior to randomization (most recent measurement must be used to determine eligibility with no interim event signaling potential deterioration in ejection fraction)

    • Left ventricular ejection fraction (LVEF) ≥45% and

    • Structural changes indicated by at least one of the following parameters:

      • Left ventricle (LV) hypertrophy (any of the following: intraventricular septal or posterior wall thickness ≥1.1 cm, and/or LV mass index ≥115 g/m*2 in male and ≥95 g/m*2 in female), or
      • Left atrium (LA) enlargement (any of the following: left atrial volume (LAV) index ≥29 ml/m*2, or LAV >58 mL in male and >52 mL in female patients, or LA area >20 cm*2, or LA diameter >40 mm in male and >38 mm in female patients)
  • NYHA class II or III at randomization

Exclusion Criteria:

  • Clinical instability at randomization, defined by

    • Any IV treatment within 24h prior to randomization, and/or
    • SBP ≥160 mmHg
    • SBP <110 mmHg and/or DBP <40 mmHg and/or symptomatic hypotension
    • Resting heart rate (HR) <50 or ≥100 beats per minute (bpm)
  • Use of IV inotropes at any time between qualifying HF event and randomization
  • Previous diagnosis of reduced ejection fraction (EF) (EF <40%)
  • Hypertrophic obstructive cardiomyopathy, acute myocarditis, amyloidosis, sarcoidosis, or pericardial disease
  • Primary valvular heart disease requiring surgery or intervention, or within 3 months after valvular surgery or intervention, or active endocarditis
  • Acute coronary syndrome, including unstable angina, Non ST-elevation myocardial infarction or ST-elevation myocardial infarction, or Coronary artery bypass grafting (CABG) within 60 days prior to randomization, or indication for Percutaneous coronary intervention or CABG at the time of randomization
  • Symptomatic carotid stenosis, or transient ischemic attack or stroke within 60 days prior to randomization
  • Complex congenital heart disease

  • Non-cardiac comorbidity (any of the following)

    • Estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m*2 calculated by Modification of Diet in Renal Disease formula
    • Hepatic insufficiency classified as Child-Pugh B or C
    • Morbid obesity with a body mass index >45 kg/m*2
    • Malignancy or other non-cardiac condition limiting life expectancy to <1 year, per physician judgment
    • Requires continuous home oxygen for severe pulmonary disease or has interstitial lung disease
    • Patients with allergies, intolerance or hypersensitivity to investigational drug or any of the excipients
  • Concurrent or anticipated use of nitrates or NO donors, phosphodiesterase type V (PDE5) inhibitors, or a Soluble guanylate cyclase (sGC) stimulator
Contacts and Locations
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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): NCT03547583


Locations
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Sponsors and Collaborators
Bayer
Merck Sharp & Dohme LLC
Canadian VIGOUR Centre
Duke Clinical Research Institute
  Study Documents (Full-Text)

Documents provided by Bayer:
Study Protocol  [PDF] February 22, 2018
Statistical Analysis Plan  [PDF] November 21, 2019

More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03547583    
Other Study ID Numbers: 19334
2018-000298-65 ( EudraCT Number )
First Posted: June 6, 2018    Key Record Dates
Results First Posted: December 3, 2020
Last Update Posted: January 6, 2021
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases