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A Pilot Feasibility Study in Recovered Heart Failure (TRED)

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: NCT02859311
Recruitment Status : Unknown
Verified November 2017 by Royal Brompton & Harefield NHS Foundation Trust.
Recruitment status was:  Active, not recruiting
First Posted : August 9, 2016
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust

Brief Summary:
One third of patients diagnosed with heart failure demonstrate left ventricular reverse remodelling and recovery of cardiac function following a period of medical therapy. These patients have an excellent long-term prognosis. Whether they need to remain on long-term medical therapy is not clear. The investigators will investigate the safety of therapy withdrawal in patients with a previous diagnosis of heart failure and recovered cardiac function, in a randomised controlled trial.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Withdrawal of therapy Phase 4

Detailed Description:

Patients with a previous diagnosis of heart failure, who have recovered cardiac function, without symptoms, normal serum biomarker concentrations and who are currently still taking heart failure medications, will be recruited. Participants will be randomised to withdrawal of therapy and control arms and will undergo imaging investigations and cardiopulmonary exercise tests at baseline along with serum biomarker tests. Those participants randomised to withdrawal of therapy will have a gradual, supervised reduction of medications. If, at anytime, there are signs of recurring heart failure, medications will be restarted. Participants in the control arm will continue their medical therapy as usual.

Participants will be followed up with further biomarker testing, cardiopulmonary exercise testing and imaging investigations at 6 months.

The primary end-point will be a relapse in heart failure, defined by adverse remodelling, increase in left ventricular size, rise in serum biomarkers or clinical evidence of heart failure as judged by the clinical team.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Feasibility Study in Recovered Heart Failure
Study Start Date : April 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Withdrawal of therapy
Gradual, supervised withdrawal of medical therapy over 4-16 weeks
Drug: Withdrawal of therapy
Withdrawal of heart failure therapies (angiotensin converting enzyme inhibitors, angiotensin receptor blockers, beta-blockers, mineralocorticoid receptor antagonists and loop diuretics)

No Intervention: Control
Continuation of usually prescribed pharmacological therapy



Primary Outcome Measures :
  1. Heart failure relapse [ Time Frame: 6 months ]
    Defined by one of the following: 1) A reduction in left ventricular ejection fraction; 2) An increase in left ventricular size; 3) An increase in serum biomarker concentration from baseline; 4) Clinical evidence of heart failure


Secondary Outcome Measures :
  1. Cardiopulmonary exercise testing with peak oxygen consumption [ Time Frame: 6 months ]
    Change in peak oxygen consumption between baseline and follow-up test

  2. Quality of life [ Time Frame: 6 months ]
    Patient questionnaires - Kansas City Cardiomyopathy Questionnaire and Heart Failure Symptom Questionnaire (symptom scores are calculated on the basis of the participants' answers to the questionnaires)

  3. Major adverse cardiovascular events (MACE) - safety end-point [ Time Frame: 6 months ]
    MACE - unplanned cardiovascular (CV) hospitalisation, CV mortality and major adverse CV events (non-fatal myocardial infarction and non-fatal cerebrovascular accident)

  4. Percentage of participants with new and sustained arrhythmias [ Time Frame: 6 months ]
    New and sustained arrhythmias diagnosed during follow-up

  5. Increase in left atrial volume as measured on cardiovascular magnetic resonance (CMR) [ Time Frame: 6 months ]
    Increase in left atrial volume as measured on CMR (in millilitres)



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have an index diagnosis of heart failure confirmed by 2 independent operators based on clinical details.
  2. Be currently taking at least 1 of the following medications loop diuretic, betablocker, angiotension converting enzyme inhibitor/angiotensin receptor blocker and mineralocorticoid receptor antagonist.
  3. Have demonstrated evidence of left ventricular reverse remodelling following the initial diagnosis with subsequent improvement in ejection fraction to >50% and normalisation of left ventricular (LV) volumes.
  4. Have no symptoms of heart failure (NYHA Class 1).
  5. Low plasma NTproBNP.

Exclusion Criteria:

  1. Uncontrolled hypertension.
  2. More than moderate valvular disease.
  3. Estimated glomerular filtration rate <30mls/min.
  4. Atrial/supraventricular/ventricular arrhythmia requiring beta-blockade.
  5. Pregnancy.
  6. Unstable angina.
  7. Age <16 years

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): NCT02859311


Locations
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United Kingdom
Royal Brompton and Harefield NHS Trust
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Investigators
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Principal Investigator: Sanjay Prasad, MD Royal Brompton and Harefield NHS Foundation Trust

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02859311    
Other Study ID Numbers: 2015CD007B
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
Recovery
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases