Heart Failure With Reduced Ejection FractionPhase 4DAPA-VO2NCT04197635
Short-term Effects of Dapagliflozin on Peak VO2 in HFrEF
A Phase 4 study testing Maximal functional capacity by cardiopulmonary exercise testing, Echocardiography and Evaluation of health related quality of life in people with Heart Failure With Reduced Ejection Fraction, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
Trial summary
This study will be a double-blind multicenter randomized study (1:1) to evaluate the effect of dapagliflozin 10 mg per day or placebo on short-term functional capacity evaluated through changes in peak oxygen consumption. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Maximal functional capacity by cardiopulmonary exercise testing, Echocardiography and Evaluation of health related quality of life
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2019to 19 Apr 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participant or his legal representative is willing and able to give informed consent for participation in the study.
- Male or female, aged ≥18 years.
- Established documented diagnosis of symptomatic HF (NYHA functional class II-III), which has been present for at least 2 months.
- LVEF ≤40% documented in the last 3 months by echocardiography or cardiac magnetic resonance.
- NT-proBNP ≥600 pg/ml.
- Patients should receive background standard of care for HFrEF at judgment of the investigator.
- Estimated glomerular filtration rate (eGFR) ≥30 ml/min/1.73m2 (DMRD formula) at enrolment.
Who cannot join
- Inability to perform a valid (respiratory exchange ratio -RER- ≥1.05) baseline cardiopulmonary exercise test (CPET)
- Patients receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment, or previous intolerance of an SGLT2 inhibitor
- Type 1 diabetes
- Symptomatic hypotension or systolic blood pressure <95 mmHg
- Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
- Myocardial infarction, unstable angina, stroke, or transient ischemic attack within 12 weeks prior to enrolment
Show all 15Show fewer
- Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or cardiac valve repair/replacement within 12 weeks prior to enrolment, or planned to undergo any of these operations after randomization
- Implantation of a cardiac resynchronization therapy (CRT) device within 12 weeks prior to enrolment or intent to implant a CRT device
- Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
- HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy, or uncorrected severe primary cardiac valve disease
- Symptomatic bradycardia or second or third-degree heart block without a pacemaker
- Severe renal dysfunction (eGFR<30 ml/min/1.73m2) or prior admission for acute renal failure in the last 4 weeks.
- Pregnant or lactating women
- Woman of childbearing age, unless they are using highly effective contraceptive methods.
- Patients with severe hepatic impairment (Child-Pugh class C).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-term Effects of Dapagliflozin on Peak VO2 in Patients With Heart Failure With Reduced Ejection Fraction
This study will be a double-blind multicenter randomized study (1:1) to evaluate the effect of dapagliflozin 10 mg per day or placebo on short-term functional capacity evaluated through changes in peak oxygen consumption.
Read the detailed description
This study will be a double-blind multicenter randomized study (1:1) to evaluate the effect of dapagliflozin 10 mg per day or placebo on short-term functional capacity evaluated through changes in peak oxygen consumption. This trial will include patients with stable symptomatic heart failure with reduced ejection fraction (HFrEF). Efficacy endpoints will be evaluated at 3 time points: 1) baseline (before dapagliflozin/placebo administration), 2) 30 days after randomization, and, 3) 90 days after randomization. An intermediate clinical visit will be performed one week after study initiation.
Pre-and post-treatment evaluations (at baseline, 30 and 90 days) will include clinical assessment, cardiopulmonary exercise stress test, echocardiography, 6-minute walk test (6MWT), and quality of life indicators (Minnesota Living with Heart Failure Questionnaire -MLHFQ).
The investigators postulate that dapagliflozin 10 mg/day improves short-term functional capacity of patients with symptomatic HFrEF through multifactorial mechanisms, such as diuretic effect and improvement in myocardial energetic efficiency.
- Being tested
- Maximal functional capacity by cardiopulmonary exercise testing, Echocardiography, Evaluation of health related quality of life, Submáximal functional capacity assesment by 6 minutes walk test, Clinical evaluation
- Keywords
- Heart Failure with Reduced Ejection Fraction, Functional Capacity, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maximal functional capacity by cardiopulmonary exercise testingDiagnostic test
Also called peak oxygen consumption
It will be done with cycle ergometer (CORTEX Metamax3B), starting with 10W of power and increasing 10W every minute. During the test, heart rate, rhythm and blood pressure will be monitored. Gas exchange data shall be evaluated every 10 seconds and the peak oxygen consumption (peak VO2) shall be considered the maximum value obtained during the last 20 seconds of exercise. The main parameters to be determined are: maximum functional capacity, peak VO2, slope of the VE/VCO2 ratio, and chronotropic incompetence variables. It will be performed by a trained cardiologist blind to study treatment at baseline and at 30 and 90 days after treatment initiation.
EchocardiographyDiagnostic test
Also called Diastolic and Systolic function
The following parameters will be evaluated: a)left ventricular volumes; b) left ventricular systolic function; and c)left atrial volume and E/e' ratio. It will be performed by a trained cardiologist blind to study treatment at baseline and at 30 and 90 days after treatment initiation.
Evaluation of health related quality of lifeBehavioural
Also called Quality of life
Assessment of the quality of life through the Minnesota Living with Heart Failure Questionnaire (MLHFQ), Spanish version. It will be completed at baseline and at 30 and 90 days after treatment initiation. The score of the questionnaire is 0 to 105 points.
Submáximal functional capacity assesment by 6 minutes walk testDiagnostic test
Also called 6 minutes walk test
It will be performed in an area equipped for cardiopulmonary resuscitation. Subjects will be asked not to perform a vigorous physical exercise in the previous 2 hours. They will be allowed to have a light meal before the test. Before the test, the vital signs will be determined in a seated position after a rest of 10 minutes. Subjects will be instructed to walk at their own pace to cover as much distance as possible in 6 minutes. It will be performed by a trained nurse blind to study treatment at baseline and at 30 and 90 days after treatment initiation.
Clinical evaluationOther
Evaluation of signs and symptoms of heart failure
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin 10 mg | Active comparator | After providing informed consent, patients will be randomly assigned to receive dapagliflozin 10 mg per day. Receives: Diagnostic Test: Maximal functional capacity by cardiopulmonary exercise testing; Diagnostic Test: Echocardiography; Behavioral: Evaluation of health related quality of life; Diagnostic Test: Submáximal functional capacity assesment by 6 minutes walk test; Other: Clinical evaluation |
| Placebo identical to dapagliflozin 10 mg | Placebo comparator | After providing informed consent, patients will be randomly assigned to receive placebo (one tablet a day orally). Receives: Diagnostic Test: Maximal functional capacity by cardiopulmonary exercise testing; Diagnostic Test: Echocardiography; Behavioral: Evaluation of health related quality of life; Diagnostic Test: Submáximal functional capacity assesment by 6 minutes walk test; Other: Clinical evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity
Changes in peak oxygen consumption (VO2) at baseline, 30 and 90 days after starting treatment with dapagliflozin or placebo. VO2 is only one measure and is expressed as milliliters of oxygen per kilogram of body weight per minute (oxygen in milliliters, weight in kilograms, and time in minutes and expressed in ml/kg/min).
Measured: At baseline, 30 and 90 days after starting treatment with dapagliflozin or placebo.
Secondary outcomes (6)
Left ventricular volumes
The following parameters will be evaluated:
Left ventricular diastolic volume (measured in milliliters, mL) and systolic volume (measured in milliliters, mL) It will be performed by a trained cardiologist blind to study treatment at baseline and at 30 and 90 days after treatment initiation.
Measured: At baseline, 30 and 90 days after starting treatment with dapagliflozin or placebo.
Left ventricular ejection fraction
The following parameter will be evaluated:
Left ventricular ejection fraction (measured by simpson method and expressed in percentage, %).
It will be performed by a trained cardiologist blind to study treatment at baseline and at 30 and 90 days after treatment initiation.
Measured: At baseline, 30 and 90 days after starting treatment with dapagliflozin or placebo.
Left atrial volume
The following parameter will be evaluated:
Determination of 2-dimensional derived left atrial volume (volumen measured in milliliters, mL) indexed for body surface area (body surface area expressed in square meters -m2-) and expressed in mL/m2.
It will be performed by a trained cardiologist blind to study treatment at baseline and at 30 and 90 days after treatment initiation.
Measured: At baseline, 30 and 90 days after starting treatment with dapagliflozin or placebo.
Echocardiographic parameters of diastolic function
The following parameter of diastolic function will be evaluated:
- E/e' ratio: value of E velocity-expressed in cm/s- / averaged value of septal and lateral side e´velocity - expressed in cm/s- of the mitral annulus by pulsed tissue Doppler.
It will be performed by a trained cardiologist blind to study treatment at baseline and at 30 and 90 days after treatment initiation.
Measured: At baseline, 30 and 90 days after starting treatment with dapagliflozin or placebo.
Evaluation of health related quality of life by Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Assessment of the quality of life through the Minnesota Living with Heart Failure Questionnaire (MLHFQ). It will be completed at baseline and at 30 and 90 days after treatment initiation. The score values are ranged between 0 to 105 points.
Measured: At 30 and 90 days after starting treatment with dapagliflozin or placebo.
Submáximal functional capacity assesment by 6 minutes walk test
It will be performed in an area equipped for cardiopulmonary resuscitation. Subjects will be asked not to perform vigorous physical exercise in the previous 2 hours. They will be allowed to have a light meal before the test. Before the test, the vital signs will be determined in a seated position after a rest of 10 minutes. Subjects will be instructed to walk at their own pace to cover as much distance (measured in meters) as possible in 6 minutes. It will be performed by a trained nurse blind to study treatment at baseline and at 30 and 90 days after treatment initiation.
Measured: at 30 and 90 days after starting treatment with dapagliflozin or placebo.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start1 Jun 2019
- Primary completion14 Aug 2021
- Study completion19 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be a double-blind multicenter randomized study (1:1) to evaluate the effect of dapagliflozin 10 mg per day or placebo on short-term functional capacity evaluated through changes in peak oxygen consumption The patients will be randomized to receive dapagliflozin or placebo. Once the inclusion criteria are fulfilled and the informed consent signed, patients will be randomized, and efficacy endpoints will be evaluated at 3 time points: 1) baseline (before dapagliflozin/placebo administration), 2) 30 days after randomization, and, 3) 90 days after randomization.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julio Nuñez, Fundación para la Investigación del Hospital Clínico de Valencia
- Investigators
- Julio Nuñez Villota, Principal investigator, Fundación para la Investigación del Hospital Clínico de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197635
- Sponsor's protocol ID
- ESR-17-13447(DAPA-HF)
- Other IDs
- 2018-002614-12, 2018
- Acronym
- DAPA-VO2
- Status last verified
- Apr 2022
- First submitted
- 1 Nov 2019
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nunez J, Palau P, Dominguez E, Mollar A, Nunez E, Ramon JM, Minana G, Santas E, Facila L, Gorriz JL, Sanchis J, Bayes-Genis A. Early effects of empagliflozin on exercise tolerance in patients with heart failure: A pilot study. Clin Cardiol. 2018 Apr;41(4):476-480. doi: 10.1002/clc.22899. Epub 2018 Apr 17.
PubMed 29663436Lorenzo M, Jacobs-Cacha C, Palau P, Amiguet M, Seller J, Nunez E, Espriella R, Gorriz JL, Minana G, Sanchis J, Bayes-Genis A, Soler MJ, Packer M, Nunez J; DAPA-VO2 Investigators. Short-Term Changes in Peak VO2 After Initiation of Dapagliflozin in Heart Failure Across Iron Status. JACC Heart Fail. 2023 Nov;11(11):1611-1622. doi: 10.1016/j.jchf.2023.07.010. Epub 2023 Sep 6.
PubMed 37676213Amiguet M, Palau P, Dominguez E, Seller J, Pinilla JMG, de la Espriella R, Minana G, Valle A, Sanchis J, Gorriz JL, Bayes-Genis A; DAPA VO2 investigators; Nunez J. Dapagliflozin and short-term changes on circulating antigen carbohydrate 125 in heart failure with reduced ejection fraction. Sci Rep. 2023 Jun 30;13(1):10591. doi: 10.1038/s41598-023-37491-5.
PubMed 37391470Palau P, Amiguet M, Dominguez E, Sastre C, Mollar A, Seller J, Garcia Pinilla JM, Larumbe A, Valle A, Gomez Doblas JJ, de la Espriella R, Minana G, Mezcua AR, Santas E, Bodi V, Sanchis J, Pascual-Figal D, Gorriz JL, Bayes-Genis A, Nunez J; DAPA-VO2 Investigators (see Appendix). Short-term effects of dapagliflozin on maximal functional capacity in heart failure with reduced ejection fraction (DAPA-VO2 ): a randomized clinical trial. Eur J Heart Fail. 2022 Oct;24(10):1816-1826. doi: 10.1002/ejhf.2560. Epub 2022 Jun 6.
PubMed 35604416
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of Dapagliflozin on Peak VO2 in Patients With Heart Failure With Reduced Ejection Fraction
- ClinicalTrials.gov ID
- NCT04197635
- Acronym / sponsor ID
- DAPA-VO2 / ESR-17-13447(DAPA-HF)
- Keywords
- Heart Failure with Reduced Ejection Fraction, Functional Capacity, Quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 14 Aug 2021 (actual)
- Study completion
- 19 Apr 2022 (actual)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be a double-blind multicenter randomized study (1:1) to evaluate the effect of dapagliflozin 10 mg per day or placebo on short-term functional capacity evaluated through changes in peak oxygen consumption.
Detailed description
This study will be a double-blind multicenter randomized study (1:1) to evaluate the effect of dapagliflozin 10 mg per day or placebo on short-term functional capacity evaluated through changes in peak oxygen consumption. This trial will include patients with stable symptomatic heart failure with reduced ejection fraction (HFrEF). Efficacy endpoints will be evaluated at 3 time points: 1) baseline (before dapagliflozin/placebo administration), 2) 30 days after randomization, and, 3) 90 days after randomization. An intermediate clinical visit will be performed one week after study initiation.
Pre-and post-treatment evaluations (at baseline, 30 and 90 days) will include clinical assessment, cardiopulmonary exercise stress test, echocardiography, 6-minute walk test (6MWT), and quality of life indicators (Minnesota Living with Heart Failure Questionnaire -MLHFQ).
The investigators postulate that dapagliflozin 10 mg/day improves short-term functional capacity of patients with symptomatic HFrEF through multifactorial mechanisms, such as diuretic effect and improvement in myocardial energetic efficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study will be a double-blind multicenter randomized study (1:1) to evaluate the effect of dapagliflozin 10 mg per day or placebo on short-term functional capacity evaluated through changes in peak oxygen consumption The patients will be randomized to receive dapagliflozin or placebo. Once the inclusion criteria are fulfilled and the informed consent signed, patients will be randomized, and efficacy endpoints will be evaluated at 3 time points: 1) baseline (before dapagliflozin/placebo administration), 2) 30 days after randomization, and, 3) 90 days after randomization.
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin 10 mg | Active comparator | Diagnostic Test: Maximal functional capacity by cardiopulmonary exercise testing, Diagnostic Test: Echocardiography, Behavioral: Evaluation of health related quality of life, Diagnostic Test: Submáximal functional capacity assesment by 6 minutes walk test, Other: Clinical evaluationAfter providing informed consent, patients will be randomly assigned to receive dapagliflozin 10 mg per day. |
| Placebo identical to dapagliflozin 10 mg | Placebo comparator | Diagnostic Test: Maximal functional capacity by cardiopulmonary exercise testing, Diagnostic Test: Echocardiography, Behavioral: Evaluation of health related quality of life, Diagnostic Test: Submáximal functional capacity assesment by 6 minutes walk test, Other: Clinical evaluationAfter providing informed consent, patients will be randomly assigned to receive placebo (one tablet a day orally). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The participant or his legal representative is willing and able to give informed consent for participation in the study.
- Male or female, aged ≥18 years.
- Established documented diagnosis of symptomatic HF (NYHA functional class II-III), which has been present for at least 2 months.
- LVEF ≤40% documented in the last 3 months by echocardiography or cardiac magnetic resonance.
- NT-proBNP ≥600 pg/ml.
Key exclusion criteria (15 listed)
- Inability to perform a valid (respiratory exchange ratio -RER- ≥1.05) baseline cardiopulmonary exercise test (CPET)
- Patients receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment, or previous intolerance of an SGLT2 inhibitor
- Type 1 diabetes
- Symptomatic hypotension or systolic blood pressure <95 mmHg
- Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maximal functional capacity by cardiopulmonary exercise testingAlso: peak oxygen consumptionIt will be done with cycle ergometer (CORTEX Metamax3B), starting with 10W of power and increasing 10W every minute. During the test, heart rate, rhythm and blood pressure will be monitored. Gas exchange data shall be evaluated every 10 seconds and the peak oxygen consumption (peak VO2) shall be considered the maximum value obtained during the last 20 seconds of exercise. The main parameters to be determined are: maximum functional capacity, peak VO2, slope of the VE/VCO2 ratio, and chronotropic incompetence variables. It will be performed by a trained cardiologist blind to study treatment at baseline and at 30 and 90 days after treatment initiation. | Diagnostic test | Dapagliflozin 10 mg, Placebo identical to dapagliflozin 10 mg |
| EchocardiographyAlso: Diastolic and Systolic functionThe following parameters will be evaluated: a)left ventricular volumes; b) left ventricular systolic function; and c)left atrial volume and E/e' ratio. It will be performed by a trained cardiologist blind to study treatment at baseline and at 30 and 90 days after treatment initiation. | Diagnostic test | Dapagliflozin 10 mg, Placebo identical to dapagliflozin 10 mg |
| Evaluation of health related quality of lifeAlso: Quality of lifeAssessment of the quality of life through the Minnesota Living with Heart Failure Questionnaire (MLHFQ), Spanish version. It will be completed at baseline and at 30 and 90 days after treatment initiation. The score of the questionnaire is 0 to 105 points. | Behavioural | Dapagliflozin 10 mg, Placebo identical to dapagliflozin 10 mg |
| Submáximal functional capacity assesment by 6 minutes walk testAlso: 6 minutes walk testIt will be performed in an area equipped for cardiopulmonary resuscitation. Subjects will be asked not to perform a vigorous physical exercise in the previous 2 hours. They will be allowed to have a light meal before the test. Before the test, the vital signs will be determined in a seated position after a rest of 10 minutes. Subjects will be instructed to walk at their own pace to cover as much distance as possible in 6 minutes. It will be performed by a trained nurse blind to study treatment at baseline and at 30 and 90 days after treatment initiation. | Diagnostic test | Dapagliflozin 10 mg, Placebo identical to dapagliflozin 10 mg |
| Clinical evaluationEvaluation of signs and symptoms of heart failure | Other | Dapagliflozin 10 mg, Placebo identical to dapagliflozin 10 mg |
Primary outcome
Functional capacity
Time frame: At baseline, 30 and 90 days after starting treatment with dapagliflozin or placebo.
Changes in peak oxygen consumption (VO2) at baseline, 30 and 90 days after starting treatment with dapagliflozin or placebo. VO2 is only one measure and is expressed as milliliters of oxygen per kilogram of body weight per minute (oxygen in milliliters, weight in kilograms, and time in minutes and expressed in ml/kg/min).
6 secondary outcomes
Left ventricular volumes
Time frame: At baseline, 30 and 90 days after starting treatment with dapagliflozin or placebo.
Left ventricular ejection fraction
Time frame: At baseline, 30 and 90 days after starting treatment with dapagliflozin or placebo.
Left atrial volume
Time frame: At baseline, 30 and 90 days after starting treatment with dapagliflozin or placebo.
Echocardiographic parameters of diastolic function
Time frame: At baseline, 30 and 90 days after starting treatment with dapagliflozin or placebo.
Evaluation of health related quality of life by Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Time frame: At 30 and 90 days after starting treatment with dapagliflozin or placebo.
Submáximal functional capacity assesment by 6 minutes walk test
Time frame: at 30 and 90 days after starting treatment with dapagliflozin or placebo.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Background: PubMed 29663436Nunez J, Palau P, Dominguez E, Mollar A, Nunez E, Ramon JM, Minana G, Santas E, Facila L, Gorriz JL, Sanchis J, Bayes-Genis A. Early effects of empagliflozin on exercise tolerance in patients with heart failure: A pilot study. Clin Cardiol. 2018 Apr;41(4):476-480. doi: 10.1002/clc.22899. Epub 2018 Apr 17.
- Derived from this study: PubMed 37676213Lorenzo M, Jacobs-Cacha C, Palau P, Amiguet M, Seller J, Nunez E, Espriella R, Gorriz JL, Minana G, Sanchis J, Bayes-Genis A, Soler MJ, Packer M, Nunez J; DAPA-VO2 Investigators. Short-Term Changes in Peak VO2 After Initiation of Dapagliflozin in Heart Failure Across Iron Status. JACC Heart Fail. 2023 Nov;11(11):1611-1622. doi: 10.1016/j.jchf.2023.07.010. Epub 2023 Sep 6.
- Derived from this study: PubMed 37391470Amiguet M, Palau P, Dominguez E, Seller J, Pinilla JMG, de la Espriella R, Minana G, Valle A, Sanchis J, Gorriz JL, Bayes-Genis A; DAPA VO2 investigators; Nunez J. Dapagliflozin and short-term changes on circulating antigen carbohydrate 125 in heart failure with reduced ejection fraction. Sci Rep. 2023 Jun 30;13(1):10591. doi: 10.1038/s41598-023-37491-5.
- Derived from this study: PubMed 35604416Palau P, Amiguet M, Dominguez E, Sastre C, Mollar A, Seller J, Garcia Pinilla JM, Larumbe A, Valle A, Gomez Doblas JJ, de la Espriella R, Minana G, Mezcua AR, Santas E, Bodi V, Sanchis J, Pascual-Figal D, Gorriz JL, Bayes-Genis A, Nunez J; DAPA-VO2 Investigators (see Appendix). Short-term effects of dapagliflozin on maximal functional capacity in heart failure with reduced ejection fraction (DAPA-VO2 ): a randomized clinical trial. Eur J Heart Fail. 2022 Oct;24(10):1816-1826. doi: 10.1002/ejhf.2560. Epub 2022 Jun 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julio Nuñez Villota principal investigator
Fundación para la Investigación del Hospital Clínico de Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Maximal functional capacity by cardiopulmonary exercise testing, Echocardiography and Evaluation of health related quality of life in people with Heart Failure With Reduced Ejection Fraction, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity (time frame: At baseline, 30 and 90 days after starting treatment with dapagliflozin or placebo.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04197635, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.