Dilated CardiomyopathyNCT04307823
Respiratory Muscles Training in Patients With Dilated Cardiomyopathy
A study testing Treadmill training and Treadmill protocol and Respiratory training in people with Dilated Cardiomyopathy, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this study was to determine the effects of respiratory muscles training on cardiopulmonary parameters and quality of life in patients with dilated cardiomyopathy (DCM). It was a randomized control trial conducted on the calculated sample size of 22 patients divided into 2 groups. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Dilated Cardiomyopathy
- What is being tested?
- Treadmill training and Treadmill protocol and Respiratory training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Aug 2019to 30 Jan 2020
- Phase
- Interventional
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed cases of DCM
- New York Heart Association class (II)
- Clinically stable patients for at least (3) months
- Ejection Fraction (25 - 40%)
Who cannot join
- Recent myocardial infarction, exercise induced angina and Syncope,
- Atrioventricular valve disease, selected for heart transplant
- Uncontrolled hypertension.
- Uncontrolled diabetes.
- Significant pulmonary disease. Intellectual, neurological or musculoskeletal abnormalities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Respiratory Muscles Training on Cardiopulmonary Parameters and Quality of Life in Patients With Dilated Cardiomyopathy
The aim of this study was to determine the effects of respiratory muscles training on cardiopulmonary parameters and quality of life in patients with dilated cardiomyopathy (DCM). It was a randomized control trial conducted on the calculated sample size of 22 patients divided into 2 groups. Study was conducted at Shifa International Hospital Islamabad. Clinically stable, diagnosed cases of DCM aged 30 to 60 years were included in the study. Outcomes of study were ejection fraction, Left ventricular (LV) End systolic dimensions, LV End diastolic dimension, lung volumes and capacities and quality of life. Data was analyzed on Statistical Package for the Social Sciences (SPSS) version 21.
.
Read the detailed description
Dilated cardiomyopathy is the most common type of heart failure and primary source of heart replacement globally. It is characterized by poor left ventricular function,enlargement of left ventricle and systolic dysfunction. The underlying cause of DCM in adults is usually coronary artery disease, but other causes include inflammatory heart disease, myocardial toxins, and genetic defects; approximately 30% to 35% of patients are reported to have a genetic form of dilated cardiomyopathy. Most common sign and symptoms of dilated cardiomyopathy are ankle swelling, dyspnea, fatigue, elevated jugular venous pressure elevated, pulmonary rales due to reduced cardiac function with low output and elevated intra cardiac pressures. Other sign and symptoms chest pain due to reduced coronary blood flow, palpitation, syncope and sudden cardiac death. There is reduced exercise tolerance with fatigue and dyspnea, contributing to poor prognosis and quality of life.
Chronic heart failure (CHF) patients have limited capacity to exercise and have impairments in breathing function.Respiratory muscle weakness is a part of the underlying cause for exercise intolerance in patients with heart failure with reduced ejection fraction.
Pharmacological and non pharmacological management is directed to reduce clinical sign and symptoms and control of disease progression and complications like sudden cardiac arrest. Physical rehabilitation is beneficial, effective and safe for functional limitation of DCM patients. A modified Bruce protocol is usually used to gradually increase exercise intensity in cardiac rehabilitation programs for patients with cardiomyopathy. Bruce protocol was used to observe fluctuations in heart rate through a quick increase of exercise intensity for a short period of time. Some patients are able to exercise with higher intensity safely, but many patients reported difficulties on treadmill exercise. This becomes even more difficult when the intensity of the treadmill exercise is increased.
Various studies have demonstrated the effects of exercise as well as inspiratory muscle training for improvement in patients with CHF and have considered it an important component of cardiac rehabilitation. Respiratory muscles training is commonly performed using inspiratory resistance devices but studies have proven that incentive spirometry could be an interesting alternative for clinical use for the cases where there is difficult to acquire the devices. Slow breathing treatment is safe and induces favourable effects in cardiopulmonary parameters, decreases rate of dyspnea, improves exercise performance and increases respiratory muscles and function. Deeper and slow breathing involves the use of diaphragm that is activated during slow breathing and does not increase respiratory workload.Respiratory muscles training is safe and improves physiologic parameters including an increase in oxygen saturation and improved exercise capacity, leading to an improvement in health status.
This study is intended to observed the overall effect of respiratory muscles training including slow breathing and incentive spirometry along with treadmill training according to bruce protocol for improvement in their ejection fraction, left ventricular dimensions , pulmonary function and quality of life.
- Conditions
- Dilated Cardiomyopathy
- Being tested
- Treadmill training, Treadmill protocol and Respiratory training
- Keywords
- Bruce protocol, Congestive heart failure, Dilated cardiomyopathy, Incentive spirometry, Slow breathing training
- Medical subject headings
- Cardiomyopathy, Dilated, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill trainingOther
3 days per week, starting at shorter duration 5-20min and progressed to 30- 40mins.
Training% or Intensity was kept 40-70%,
Training Heart Rate (HR) was calculated through formula:
HR max HR rest*Ex intensity + HR rest Rate of Perceived Exertion (RPE) 9-14 ON 6 -20 RPE scale The session was terminated if sustained ventricular arrhythmia, symptomatic drop in blood pressure, ST elevation, or development of severe symptoms
Treadmill protocol and Respiratory trainingOther
Treadmill protocol
Spirometry:
Volumetric exercises, using incentive Spirometer 10-15 repetitions
Slow breathing training:
5 minutes: spontaneous breathing, 4 minutes: controlled breathing (15 breaths/min) 4 minutes of controlled breathing (6 breaths/min) Treatment provided for 3 days in a week for a period of 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treadmill training group | Active comparator | Treadmill training according to American College of Sports Medicine's guidelines Receives: Other: Treadmill training |
| Treadmill protocol and respiratory training group | Experimental | Treadmill training, slow breathing training and incentive spirometry Receives: Other: Treadmill protocol and Respiratory training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ejection fraction
Ejection fraction calculated through echocardiography
Measured: After 4 weeks of intervention
LV End systolic dimension
LV End systolic dimension calculated through echocardiography
Measured: After 4 weeks of intervention
LV End diastolic dimension
LV End diastolic dimension calculated through echocardiography
Measured: After 4 weeks of intervention
Secondary outcomes (5)
Memorial symptom assessment scale - Heart failure
Memorial symptom assessment scale for heart failure patients (MSAS-HF) is a patient-rated instrument to assess the quality of life of heart failure patients. It scores 32 symptoms including 26 physical symptoms of distress and 6 psychological symptoms are recorded.
Distress is rated on a 5 point scale each symptom is scored from 0 to 4 ranging from "no symptom" to "very much." If the symptom is not present, a value of zero is assigned.
Frequency of psychological symptoms is scored as 1-rarely, 2- occasionally, 3-frequently, and 4- almost constantly.
The symptom scores are combined into various sub-scales scores including the psychological sub-scale score, physical sub-scale, global distress index and total MSAS score. The mean score in each category is calculated with higher scores indicating poor quality of life.
Measured: After 4 weeks of intervention
Forced Expiratory volume 1(FEV1)
Forced Expiratory volume 1(FEV1) measured through digital spirometer. If the value of FEV1 is within 80% of the reference value, the results are considered normal.
Measured: After 4 weeks of intervention
Forced Vital capacity(FVC)
Forced Vital capacity(FVC) measured through digital spirometer. If the value of FVC is within 80% of the reference value, the results are considered normal.
Measured: After 4 weeks of intervention
FEV1/FVC
FEV1/FVC measured through digital spirometer. The normal value for the FEV1/FVC ratio is 70% (and 65% in persons older than age 65).
Measured: After 4 weeks of intervention
Peak Expiratory Flow Rate (PEFR)
Peak Expiratory Flow Rate (PEFR) measured through digital spirometer. Three zones of measurement are commonly used to interpret peak flow rates. Normal value of PEFR is (80-100%). Green zone indicates 80 to 100 percent of the usual or normal peak flow reading, yellow zone indicates 50 to 79 percent of the usual or normal peak flow readings, and red zone indicates less than 50 percent of the usual or normal peak flow readings.
Measured: After 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start15 Aug 2019
- Primary completion20 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Dilated CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suman Sheraz, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307823
- Sponsor's protocol ID
- REC/00596 Hanifa Suleman
- Status last verified
- Mar 2020
- First submitted
- 2 Mar 2020
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ziaeian B, Fonarow GC. Epidemiology and aetiology of heart failure. Nat Rev Cardiol. 2016 Jun;13(6):368-78. doi: 10.1038/nrcardio.2016.25. Epub 2016 Mar 3.
PubMed 26935038Russo MA, Santarelli DM, O'Rourke D. The physiological effects of slow breathing in the healthy human. Breathe (Sheff). 2017 Dec;13(4):298-309. doi: 10.1183/20734735.009817.
PubMed 29209423Drozdz T, Bilo G, Debicka-Dabrowska D, Klocek M, Malfatto G, Kielbasa G, Styczkiewicz K, Bednarek A, Czarnecka D, Parati G, Kawecka-Jaszcz K. Blood pressure changes in patients with chronic heart failure undergoing slow breathing training. Blood Press. 2016;25(1):4-10. doi: 10.3109/08037051.2016.1099800. Epub 2015 Oct 29.
PubMed 26513698Wasserstrum Y, Barbarova I, Lotan D, Kuperstein R, Shechter M, Freimark D, Segal G, Klempfner R, Arad M. Efficacy and safety of exercise rehabilitation in patients with hypertrophic cardiomyopathy. J Cardiol. 2019 Nov;74(5):466-472. doi: 10.1016/j.jjcc.2019.04.013. Epub 2019 Jun 22.
PubMed 31235420Gomes-Neto M, Duraes AR, Conceicao LSR, Roever L, Silva CM, Alves IGN, Ellingsen O, Carvalho VO. Effect of combined aerobic and resistance training on peak oxygen consumption, muscle strength and health-related quality of life in patients with heart failure with reduced left ventricular ejection fraction: a systematic review and meta-analysis. Int J Cardiol. 2019 Oct 15;293:165-175. doi: 10.1016/j.ijcard.2019.02.050. Epub 2019 Jun 24.
PubMed 31345646Lachowska K, Bellwon J, Morys J, Gruchala M, Hering D. Slow breathing improves cardiovascular reactivity to mental stress and health-related quality of life in heart failure patients with reduced ejection fraction. Cardiol J. 2020;27(6):772-779. doi: 10.5603/CJ.a2019.0002. Epub 2019 Jan 30.
PubMed 30697682Neto MG, Martinez BP, Conceicao CS, Silva PE, Carvalho VO. Combined Exercise and Inspiratory Muscle Training in Patients With Heart Failure: A SYSTEMATIC REVIEW AND META-ANALYSIS. J Cardiopulm Rehabil Prev. 2016 Nov/Dec;36(6):395-401. doi: 10.1097/HCR.0000000000000184.
PubMed 27182763Leggio M, Fusco A, Loreti C, Limongelli G, Bendini MG, Mazza A, Coraci D, Padua L. Effects of exercise training in heart failure with preserved ejection fraction: an updated systematic literature review. Heart Fail Rev. 2020 Sep;25(5):703-711. doi: 10.1007/s10741-019-09841-x.
PubMed 31399956
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Respiratory Muscles Training on Cardiopulmonary Parameters and Quality of Life in Patients With Dilated Cardiomyopathy
- ClinicalTrials.gov ID
- NCT04307823
- Acronym / sponsor ID
- REC/00596 Hanifa Suleman
- Conditions
- Dilated Cardiomyopathy
- Keywords
- Bruce protocol, Congestive heart failure, Dilated cardiomyopathy, Incentive spirometry, Slow breathing training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 13 Mar 2020 (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.
The aim of this study was to determine the effects of respiratory muscles training on cardiopulmonary parameters and quality of life in patients with dilated cardiomyopathy (DCM). It was a randomized control trial conducted on the calculated sample size of 22 patients divided into 2 groups. Study was conducted at Shifa International Hospital Islamabad. Clinically stable, diagnosed cases of DCM aged 30 to 60 years were included in the study. Outcomes of study were ejection fraction, Left ventricular (LV) End systolic dimensions, LV End diastolic dimension, lung volumes and capacities and quality of life. Data was analyzed on Statistical Package for the Social Sciences (SPSS) version 21.
.
Detailed description
Dilated cardiomyopathy is the most common type of heart failure and primary source of heart replacement globally. It is characterized by poor left ventricular function,enlargement of left ventricle and systolic dysfunction. The underlying cause of DCM in adults is usually coronary artery disease, but other causes include inflammatory heart disease, myocardial toxins, and genetic defects; approximately 30% to 35% of patients are reported to have a genetic form of dilated cardiomyopathy. Most common sign and symptoms of dilated cardiomyopathy are ankle swelling, dyspnea, fatigue, elevated jugular venous pressure elevated, pulmonary rales due to reduced cardiac function with low output and elevated intra cardiac pressures. Other sign and symptoms chest pain due to reduced coronary blood flow, palpitation, syncope and sudden cardiac death. There is reduced exercise tolerance with fatigue and dyspnea, contributing to poor prognosis and quality of life.
Chronic heart failure (CHF) patients have limited capacity to exercise and have impairments in breathing function.Respiratory muscle weakness is a part of the underlying cause for exercise intolerance in patients with heart failure with reduced ejection fraction.
Pharmacological and non pharmacological management is directed to reduce clinical sign and symptoms and control of disease progression and complications like sudden cardiac arrest. Physical rehabilitation is beneficial, effective and safe for functional limitation of DCM patients. A modified Bruce protocol is usually used to gradually increase exercise intensity in cardiac rehabilitation programs for patients with cardiomyopathy. Bruce protocol was used to observe fluctuations in heart rate through a quick increase of exercise intensity for a short period of time. Some patients are able to exercise with higher intensity safely, but many patients reported difficulties on treadmill exercise. This becomes even more difficult when the intensity of the treadmill exercise is increased.
Various studies have demonstrated the effects of exercise as well as inspiratory muscle training for improvement in patients with CHF and have considered it an important component of cardiac rehabilitation. Respiratory muscles training is commonly performed using inspiratory resistance devices but studies have proven that incentive spirometry could be an interesting alternative for clinical use for the cases where there is difficult to acquire the devices. Slow breathing treatment is safe and induces favourable effects in cardiopulmonary parameters, decreases rate of dyspnea, improves exercise performance and increases respiratory muscles and function. Deeper and slow breathing involves the use of diaphragm that is activated during slow breathing and does not increase respiratory workload.Respiratory muscles training is safe and improves physiologic parameters including an increase in oxygen saturation and improved exercise capacity, leading to an improvement in health status.
This study is intended to observed the overall effect of respiratory muscles training including slow breathing and incentive spirometry along with treadmill training according to bruce protocol for improvement in their ejection fraction, left ventricular dimensions , pulmonary function and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treadmill training group | Active comparator | Other: Treadmill trainingTreadmill training according to American College of Sports Medicine's guidelines |
| Treadmill protocol and respiratory training group | Experimental | Other: Treadmill protocol and Respiratory trainingTreadmill training, slow breathing training and incentive spirometry |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosed cases of DCM
- New York Heart Association class (II)
- Clinically stable patients for at least (3) months
- Ejection Fraction (25 - 40%)
Key exclusion criteria (5 listed)
- Recent myocardial infarction, exercise induced angina and Syncope,
- Atrioventricular valve disease, selected for heart transplant
- Uncontrolled hypertension.
- Uncontrolled diabetes.
- Significant pulmonary disease. Intellectual, neurological or musculoskeletal abnormalities.
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 |
|---|---|---|
| Treadmill training3 days per week, starting at shorter duration 5-20min and progressed to 30- 40mins. Training% or Intensity was kept 40-70%, Training Heart Rate (HR) was calculated through formula: HR max HR rest*Ex intensity + HR rest Rate of Perceived Exertion (RPE) 9-14 ON 6 -20 RPE scale The session was terminated if sustained ventricular arrhythmia, symptomatic drop in blood pressure, ST elevation, or development of severe symptoms | Other | Treadmill training group |
| Treadmill protocol and Respiratory trainingTreadmill protocol Spirometry: Volumetric exercises, using incentive Spirometer 10-15 repetitions Slow breathing training: 5 minutes: spontaneous breathing, 4 minutes: controlled breathing (15 breaths/min) 4 minutes of controlled breathing (6 breaths/min) Treatment provided for 3 days in a week for a period of 4 weeks | Other | Treadmill protocol and respiratory training group |
Primary outcome
Ejection fraction
Time frame: After 4 weeks of intervention
Ejection fraction calculated through echocardiography
LV End systolic dimension
Time frame: After 4 weeks of intervention
LV End systolic dimension calculated through echocardiography
LV End diastolic dimension
Time frame: After 4 weeks of intervention
LV End diastolic dimension calculated through echocardiography
5 secondary outcomes
Memorial symptom assessment scale - Heart failure
Time frame: After 4 weeks of intervention
Forced Expiratory volume 1(FEV1)
Time frame: After 4 weeks of intervention
Forced Vital capacity(FVC)
Time frame: After 4 weeks of intervention
FEV1/FVC
Time frame: After 4 weeks of intervention
Peak Expiratory Flow Rate (PEFR)
Time frame: After 4 weeks of intervention
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 13 Mar 2020.
- Background: PubMed 26935038Ziaeian B, Fonarow GC. Epidemiology and aetiology of heart failure. Nat Rev Cardiol. 2016 Jun;13(6):368-78. doi: 10.1038/nrcardio.2016.25. Epub 2016 Mar 3.
- Background: PubMed 29209423Russo MA, Santarelli DM, O'Rourke D. The physiological effects of slow breathing in the healthy human. Breathe (Sheff). 2017 Dec;13(4):298-309. doi: 10.1183/20734735.009817.
- Background: PubMed 26513698Drozdz T, Bilo G, Debicka-Dabrowska D, Klocek M, Malfatto G, Kielbasa G, Styczkiewicz K, Bednarek A, Czarnecka D, Parati G, Kawecka-Jaszcz K. Blood pressure changes in patients with chronic heart failure undergoing slow breathing training. Blood Press. 2016;25(1):4-10. doi: 10.3109/08037051.2016.1099800. Epub 2015 Oct 29.
- Background: PubMed 31235420Wasserstrum Y, Barbarova I, Lotan D, Kuperstein R, Shechter M, Freimark D, Segal G, Klempfner R, Arad M. Efficacy and safety of exercise rehabilitation in patients with hypertrophic cardiomyopathy. J Cardiol. 2019 Nov;74(5):466-472. doi: 10.1016/j.jjcc.2019.04.013. Epub 2019 Jun 22.
- Background: PubMed 31345646Gomes-Neto M, Duraes AR, Conceicao LSR, Roever L, Silva CM, Alves IGN, Ellingsen O, Carvalho VO. Effect of combined aerobic and resistance training on peak oxygen consumption, muscle strength and health-related quality of life in patients with heart failure with reduced left ventricular ejection fraction: a systematic review and meta-analysis. Int J Cardiol. 2019 Oct 15;293:165-175. doi: 10.1016/j.ijcard.2019.02.050. Epub 2019 Jun 24.
- Background: PubMed 30697682Lachowska K, Bellwon J, Morys J, Gruchala M, Hering D. Slow breathing improves cardiovascular reactivity to mental stress and health-related quality of life in heart failure patients with reduced ejection fraction. Cardiol J. 2020;27(6):772-779. doi: 10.5603/CJ.a2019.0002. Epub 2019 Jan 30.
- Background: PubMed 27182763Neto MG, Martinez BP, Conceicao CS, Silva PE, Carvalho VO. Combined Exercise and Inspiratory Muscle Training in Patients With Heart Failure: A SYSTEMATIC REVIEW AND META-ANALYSIS. J Cardiopulm Rehabil Prev. 2016 Nov/Dec;36(6):395-401. doi: 10.1097/HCR.0000000000000184.
- Background: PubMed 31399956Leggio M, Fusco A, Loreti C, Limongelli G, Bendini MG, Mazza A, Coraci D, Padua L. Effects of exercise training in heart failure with preserved ejection fraction: an updated systematic literature review. Heart Fail Rev. 2020 Sep;25(5):703-711. doi: 10.1007/s10741-019-09841-x.
- 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.
Suman Sheraz, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill training and Treadmill protocol and Respiratory training in people with Dilated Cardiomyopathy, run by Riphah International University at 1 site in Pakistan.
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 4 inclusion and 5 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 13 Mar 2020. 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 Pakistan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Ejection fraction (time frame: After 4 weeks of intervention). The study lists 3 primary outcomes in all. 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 NCT04307823, which also lists 8 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 13 Mar 2020.