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
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Drug: Withdrawal of therapy||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
- Cardiopulmonary exercise testing with peak oxygen consumption [ Time Frame: 6 months ]Change in peak oxygen consumption between baseline and follow-up test
- 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)
- 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)
- Percentage of participants with new and sustained arrhythmias [ Time Frame: 6 months ]New and sustained arrhythmias diagnosed during follow-up
- 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)
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
|Royal Brompton and Harefield NHS Trust|
|London, United Kingdom, SW3 6NP|
|Principal Investigator:||Sanjay Prasad, MD||Royal Brompton and Harefield NHS Foundation Trust|