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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03871803
Other study ID # BBLOQ-2017
Secondary ID 2017-005077-39
Status Completed
Phase Phase 4
First received
Last updated
Start date October 1, 2018
Est. completion date February 27, 2021

Study information

Verified date July 2020
Source Fundación para la Investigación del Hospital Clínico de Valencia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The pathophysiology of heart failure with preserved ejection fraction (HFpEF) is complex and multifactorial. Chronotropic incompetence has emerged as a crucial mechanism, particularly in elderly patients. Betablockers, drugs with negative chronotropic effect, are commonly used in HFpEF, despite current evidence does not support its routine use in these patients. The aim of this work is to evaluate the effect of betablockers withdrawal in patients with HFpEF and chronotropic incompetence on functional capacity assessed by the peak oxygen consumption at maximal exercise (peakVO2) at 15 and 30 days after the intervention


Description:

This is a prospective, crossover, randomized (1:1) and single center study. After randomization, clinical and cardiac rhythm will be continuously registered during 30 days. The primary endpoint (peakVO2) will be assessed by cardiopulmonary exercise testing (CPET) at 15 and 30-day in both groups. Patients with HFpEF, functional class NYHA II-III, chronic treatment with betablockers, and chronotropic incompetence will be enrolled. A sample size estimation [alfa: 0.05, power: 90%, a 15% loss rate, and delta change of mean peakVO2: +1.2 mL/kg/min (SD±2.5)] of 52 patients would be necessary to test our hypothesis. In conclusion, optimizing therapy that improve quality of life and autonomy has become a health care priority in HFpEF. The investigators believe this study will add important knowledge for the treatment of a subgroup of HFpEF.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date February 27, 2021
Est. primary completion date February 27, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Stable symptomatic patients with heart failure and preserved ejection fraction (NYHA class II-III). - NT-proBNP >125 pg/mL in the last month - Previous treatment with beta-blockers during the last 3 months - Documented chronotropic incompetence, defined as: [(heart rate at peak exercise- heart rate at baseline)] / [(220 - age) - (heart rate at baseline)] < 0.62 Exclusion Criteria: - Moderate to severe valvulopathy or miocardiopathy associated - Patient with heart failure with recovered ejection fraction - Acute Coronary Syndrome in the previous 12 months - Angina or signs of myocardial ischemia on cardiopulmonary exercise testing - Baseline heart rate>75 bpm. - Uncontrolled hypertension, defined as >140mmHg systolic blood pressure and/or >90 mmHg diastolic blood pressure. - Moderate to severe pulmonary disease associated - Extracardiac comorbidity with a life expentancy less than 1 year. - Unable to perform an adequate cardiopulmonary exersice test - Previous treatment with digitalis or calcium channel blockers

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Controlled withdrawal of beta-blockers
Controlled withdrawal of previos doses of beta-blockers after diagnosis of chronotropic incompetence
Diagnostic Test:
Cardiopulmonary Exercise Testing
Cardiopulmonary Exercise Testing to evaluate the chronotropic incompetence and the primary endpoint (functional capacity)

Locations

Country Name City State
Spain INCLIVA Valencia

Sponsors (1)

Lead Sponsor Collaborator
Fundación para la Investigación del Hospital Clínico de Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Domínguez E, Palau P, Núñez E, Ramón JM, López L, Melero J, Bellver A, Santas E, Chorro FJ, Núñez J. Heart rate response and functional capacity in patients with chronic heart failure with preserved ejection fraction. ESC Heart Fail. 2018 Aug;5(4):579-585. doi: 10.1002/ehf2.12281. Epub 2018 Mar 24. — View Citation

Palau P, Domínguez E, Sanchis J, Bayés-Genis A, Núñez J. Heart Rate in Heart Failure With Preserved Ejection Fraction: Another Example of the Heterogeneity of This Syndrome. JACC Heart Fail. 2018 Apr;6(4):350-351. doi: 10.1016/j.jchf.2017.12.003. — View Citation

Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, González-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. Erratum in: Eur Heart J. 2016 Dec 30;:. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Maximal functional capacity Maximal functional capacity measured by peak oxygen consumption in the cardiopulmonary exercise testing (CPET). The peak oxygen consumption is expressed in mL/kg/min.The investigators will measure the change of peak oxygen consumption . The change in peak oxygen consumption will be measured at baseline, at 15-day and at 30-day
Secondary Cognitive evaluation We will asses the cognitive function by Mini Mental State Examination (MMSE) The MMSE is a cognitive test. The score is ranged from 0-30 (units of a scale). 30 points is the better outcome. The investigators will assess the change in the score. The change in MMSE score will be measured at baseline, at 15-day and at 30-day
Secondary Cognitive evaluation We will asses the cognitive function by Montreal Cognitive Assessment (MoCa) The MoCa is a cognitive test. The score is ranged from 0-30 (units of a scale). 30 points is the better outcome. The investigators will assess the change in the score. The change in MoCa score will be measured at baseline, at 15-day and at 30-day
Secondary Quality of life evaluation We will asses the quality of life by Minnesota living with heart failure questionnaire (MLHFQ). The MLHFQ is a quality of life questionnarie .The investigators will asses the changes in the full questionnarie. We will report the total score. The score is ranged from 0-105. 105 points is the worse outcome The change in MLHFQ score will be measured at baseline, at 15-day and at 30-day
Secondary Security: reporting on potential clinical adverse outcomes Evaluation of adverse clinical outcomes during the study. The investigators will evaluate the composite of the following adverse events: mortality and/or readmissions due to cardiovascular reasons. The investigators will assess differences between both groups/arms Differences in the composite of adverse events between both arms will be measured at 15-day , at 30-day and 180-day
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