NCT02859311

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4 heart-failure

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

November 9, 2017

Status Verified

November 1, 2017

Enrollment Period

2.3 years

First QC Date

April 14, 2016

Last Update Submit

November 8, 2017

Conditions

Heart Failure

Keywords

Recovery

Outcome Measures

Primary Outcomes (1)

  • Heart failure relapse

    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

    6 months

Secondary Outcomes (5)

  • Cardiopulmonary exercise testing with peak oxygen consumption

    6 months

  • Quality of life

    6 months

  • Major adverse cardiovascular events (MACE) - safety end-point

    6 months

  • Percentage of participants with new and sustained arrhythmias

    6 months

  • Increase in left atrial volume as measured on cardiovascular magnetic resonance (CMR)

    6 months

Study Arms (2)

Withdrawal of therapy

EXPERIMENTAL

Gradual, supervised withdrawal of medical therapy over 4-16 weeks

Drug: Withdrawal of therapy

Control

NO INTERVENTION

Continuation of usually prescribed pharmacological therapy

Interventions

Withdrawal of therapyDRUG

Withdrawal of heart failure therapies (angiotensin converting enzyme inhibitors, angiotensin receptor blockers, beta-blockers, mineralocorticoid receptor antagonists and loop diuretics)

Withdrawal of therapy

Eligibility Criteria

Age16 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Have an index diagnosis of heart failure confirmed by 2 independent operators based on clinical details.
  • Be currently taking at least 1 of the following medications loop diuretic, betablocker, angiotension converting enzyme inhibitor/angiotensin receptor blocker and mineralocorticoid receptor antagonist.
  • 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.
  • Have no symptoms of heart failure (NYHA Class 1).
  • Low plasma NTproBNP.

You may not qualify if:

  • Uncontrolled hypertension.
  • More than moderate valvular disease.
  • Estimated glomerular filtration rate \<30mls/min.
  • Atrial/supraventricular/ventricular arrhythmia requiring beta-blockade.
  • Pregnancy.
  • Unstable angina.
  • Age \<16 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Brompton and Harefield NHS Trust

London, SW3 6NP, United Kingdom

Location

Related Publications (2)

  • Halliday BP, Vazir A, Owen R, Gregson J, Wassall R, Lota AS, Khalique Z, Tayal U, Jones RE, Hammersley D, Pantazis A, Baksi AJ, Rosen S, Pennell DJ, Cowie MR, Cleland JGF, Prasad SK. Heart Rate as a Marker of Relapse During Withdrawal of Therapy in Recovered Dilated Cardiomyopathy. JACC Heart Fail. 2021 Jul;9(7):509-517. doi: 10.1016/j.jchf.2021.03.010. Epub 2021 Jun 9.

    PMID: 34119469DERIVED

  • Halliday BP, Wassall R, Lota AS, Khalique Z, Gregson J, Newsome S, Jackson R, Rahneva T, Wage R, Smith G, Venneri L, Tayal U, Auger D, Midwinter W, Whiffin N, Rajani R, Dungu JN, Pantazis A, Cook SA, Ware JS, Baksi AJ, Pennell DJ, Rosen SD, Cowie MR, Cleland JGF, Prasad SK. Withdrawal of pharmacological treatment for heart failure in patients with recovered dilated cardiomyopathy (TRED-HF): an open-label, pilot, randomised trial. Lancet. 2019 Jan 5;393(10166):61-73. doi: 10.1016/S0140-6736(18)32484-X. Epub 2018 Nov 11.

    PMID: 30429050DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Sanjay Prasad, MD

    Royal Brompton and Harefield NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2016

First Posted

August 9, 2016

Study Start

April 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

November 9, 2017

Record last verified: 2017-11

Locations

GB(1)