Diabetes MellitusPhase 4NCT02962921
Insulin Effects on Cardiac Function in Patients With Diabetes Mellitus
A Phase 4 study testing Insulin LISPRO intravenous loading in people with Diabetes Mellitus and Ventricular Dysfunction, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Our investigation studies the role of acute insulin administration on the diabetic heart, its corresponding effective blood-insulin level and the time-course applicability of insulin in a routine clinical setting. Read more about this study
- Who is it for?
- Ages 30 to 65 years, men only
- Conditions the study is for
- Diabetes Mellitus, Ventricular Dysfunction
- What is being tested?
- Insulin LISPRO intravenous loading
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2003to Nov 2004
- 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 30 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes mellitus duration of 2 years and over.
Who cannot join
- Previous cardiac disease: valvular, Pacing, Arrhythmias, Primary Cardiomyopathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Insulin Effects on Cardiac Function in Patients With Diabetes Mellitus
Our investigation studies the role of acute insulin administration on the diabetic heart, its corresponding effective blood-insulin level and the time-course applicability of insulin in a routine clinical setting.
A case series of six male (48.1 ± 4.9 y/o) patients with controlled diabetes (HbA1c of 6.6 ± 0.3%, disease duration of 14.4 ± 6.7 yr). Each subject was evaluated for glucose homeostatic, hemodynamic and echocardiographic systolic and diastolic parameters at baseline and following two successive insulin-load steps of a euglycemic hyperinsulinemic clamp study, each 2 h in duration. Results are presented as a mean ± SEM and analysed using the student's t-test.
Read the detailed description
Patients:
Six male diabetic (five type 2 and one type 1) patients, 30-65 year old, with an established diagnosis of diabetes mellitus for ≥2 years, who were free of significant valvular heart disease, atrial arrhythmia or cardiac pacing comprised the study population. Patients' characteristics are summarized in table 1.
Each patient served as his or her own control. The study protocol was approved by the ethics committee at Rambam Medical Center, Haifa, Israel. Prior to the study, patients gave written informed consent after receiving a detailed explanation as to the purpose of the study, the technique, its side effects and the study protocol.
Patients were studied within a clinical research facility at the Rambam Medical Center, Haifa, Israel. Baseline evaluation was conducted at 8:00 am after 12 h of fasting, followed by two hyperinsulinemic euglycemic clamp (EHC) steps (2 h each step); The following vital signs were monitored during the study protocol: manual heart rate, systolic blood pressure (SBP), diastolic blood pressure (DBP) and baseline 12-lead electrocardiogram (ECG) recording. Glucose consumption rates against changing insulin levels were measured by the EHC technique. Cardiac function parameters were measured in the last 10 min of each step by tissue Doppler echocardiography. Results are presented as a mean ± SEM.
Clamp technique:
Each patient underwent an EHC study according to the protocol described previously, and implemented in our institute. Baseline measurements of blood insulin and glucose levels were collected. Thereafter, two insulin loads were initiated. The blood glucose level was kept near euglycemia (90 ± 5 mg/dl) throughout 2 h period of each insulin load step. Intravenous (iv) insulin loads were administered by 1- and 10-mU/kg·min at steps 1 and 2 of insulin loading (Lispro Insulin, Eli Lilly, France), respectively. Dexstrose in water 50% (DW50) was infused at variable infusion rates, titrated to maintain euglycemia. Concomitant saline 0.45% was used to dilute the DW50 in order to prevent hypertonicity-induced irritation of the cannuled vein. During the baseline period, saline 0.45% infusion rates were 0.75 ml/min to keep the iv cannule open. Every patient was given a chance to urinate before step 2.
Glucose and insulin homeostatic parameters of the study group were compared to those of healthy controls we studied earlier.
Cardiac function assessment:
Transthoracic echocardiography was performed by a qualified echocardiographer using a General Electric Vivid 3 machine (Tirat HaCarmel, Israel). Parameters were assessed as the mean of three consecutive heart beats.
Systolic echocardiographic parameters:
LV fractional shortening (LVFS) derived from end diastolic and end systolic LV dimensions; LV ejection fraction (LVEF) derived from end diastolic and end systolic LV volumes.
Diastolic echocardiographic parameters:
- Mitral valve diastolic flow parameters by pulse wave Doppler: E wave, represents early diastolic filling; A wave, represents late diastolic filling concomitant with the atrial kick, E/A ratio and E wave deceleration time (DT).
- Tissue Doppler-derived velocities of the mitral annulus: E' represents early diastolic velocity synchronous to the mitral inflow E wave, measured close to the interventricular septum (E' medial) and lateral wall (E' lateral); E' mean, derived from E' lateral and E' medial. A' represents late diastolic velocity to the synchronous mitral inflow A wave, measured close to the septum (A' medial) and lateral wall (A' lateral). A' mean is derived from A' lat. and A' med. A' reflects mitral annulus movement during atrial contraction. The E to E' ratio represents diastolic LV compliance.
Results are presented as mean ± SEM and analyzed using the student's t-test. Statistical significance considered when p value less than 0.05.
- Conditions
- Diabetes Mellitus, Ventricular Dysfunction
- Being tested
- Insulin LISPRO intravenous loading
- Medical subject headings
- Diabetes Mellitus, Ventricular Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin LISPRO intravenous loadingDrug
Also called Humalog Insulin
intravenous infusion of insulin Lispro.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients | Experimental | Diabetic patients were treated with insulin loads, left ventricle functional parameters were compared to those of healthy persons.
Metabolic indices of insulin effect: blood insulin levels, glucose disposal rates under insulin infusion, were compared to respective group of healthy persons, studied earlier at our institution Insulin LISPRO intravenous loading Receives: Drug: Insulin LISPRO intravenous loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricle ejection fraction (%)
Measured: 1 year
Secondary outcomes (1)
Time needed to exert insulin effect on myocardial function (hour)
Describe the shortest time required for insulin to change myocardial function.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study startFeb 2003
- Primary completionMay 2003
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eddy Karnieli, MD, Study chair, Professor emeritus, Faculty of medicine, Technion. Haifa, IsraelRonen Bar Yoseph, MD, Principal investigator, Pediatric Pulmonary InstituteSergey Yalonetsky, MD, Principal investigator, Cardiology Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962921
- Sponsor's protocol ID
- 1558-RMB-CTIL
- Status last verified
- Nov 2016
- First submitted
- 10 Sep 2016
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: First we need to learn how to share data
Publications
Adeghate E. Molecular and cellular basis of the aetiology and management of diabetic cardiomyopathy: a short review. Mol Cell Biochem. 2004 Jun;261(1-2):187-91. doi: 10.1023/b:mcbi.0000028755.86521.11.
PubMed 15362503Francis GS. Diabetic cardiomyopathy: fact or fiction? Heart. 2001 Mar;85(3):247-8. doi: 10.1136/heart.85.3.247. No abstract available.
PubMed 11179253Kitzman DW, Gardin JM, Gottdiener JS, Arnold A, Boineau R, Aurigemma G, Marino EK, Lyles M, Cushman M, Enright PL; Cardiovascular Health Study Research Group. Importance of heart failure with preserved systolic function in patients > or = 65 years of age. CHS Research Group. Cardiovascular Health Study. Am J Cardiol. 2001 Feb 15;87(4):413-9. doi: 10.1016/s0002-9149(00)01393-x.
PubMed 11179524Gutierrez C, Blanchard DG. Diastolic heart failure: challenges of diagnosis and treatment. Am Fam Physician. 2004 Jun 1;69(11):2609-16.
PubMed 15202695McMurray JJ, Stewart S. Epidemiology, aetiology, and prognosis of heart failure. Heart. 2000 May;83(5):596-602. doi: 10.1136/heart.83.5.596. No abstract available.
PubMed 10768918Rubler S, Dlugash J, Yuceoglu YZ, Kumral T, Branwood AW, Grishman A. New type of cardiomyopathy associated with diabetic glomerulosclerosis. Am J Cardiol. 1972 Nov 8;30(6):595-602. doi: 10.1016/0002-9149(72)90595-4. No abstract available.
PubMed 4263660Poornima IG, Parikh P, Shannon RP. Diabetic cardiomyopathy: the search for a unifying hypothesis. Circ Res. 2006 Mar 17;98(5):596-605. doi: 10.1161/01.RES.0000207406.94146.c2.
PubMed 16543510Fein FS, Strobeck JE, Malhotra A, Scheuer J, Sonnenblick EH. Reversibility of diabetic cardiomyopathy with insulin in rats. Circ Res. 1981 Dec;49(6):1251-61. doi: 10.1161/01.res.49.6.1251.
PubMed 7030513Hiramatsu K, Ohara N, Shigematsu S, Aizawa T, Ishihara F, Niwa A, Yamada T, Naka M, Momose A, Yoshizawa K. Left ventricular filling abnormalities in non-insulin-dependent diabetes mellitus and improvement by a short-term glycemic control. Am J Cardiol. 1992 Nov 1;70(13):1185-9. doi: 10.1016/0002-9149(92)90053-2.
PubMed 1414944Iliadis F, Kadoglou N, Didangelos T. Insulin and the heart. Diabetes Res Clin Pract. 2011 Aug;93 Suppl 1:S86-91. doi: 10.1016/S0168-8227(11)70019-5.
PubMed 21864757Cohen P, Harel C, Bergman R, Daoud D, Pam Z, Barzilai N, Armoni M, Karnieli E. Insulin resistance and acanthosis nigricans: evidence for a postbinding defect in vivo. Metabolism. 1990 Oct;39(10):1006-11. doi: 10.1016/0026-0495(90)90158-9.
PubMed 2215248DeFronzo RA, Tobin JD, Andres R. Glucose clamp technique: a method for quantifying insulin secretion and resistance. Am J Physiol. 1979 Sep;237(3):E214-23. doi: 10.1152/ajpendo.1979.237.3.E214.
PubMed 382871Whitlow PL, Rogers WJ, Smith LR, McDaniel HG, Papapietro SE, Mantle JA, Logic JR, Russell RO Jr, Rackley CE. Enhancement of left ventricular function by glucose-insulin-potassium infusion in acute myocardial infarction. Am J Cardiol. 1982 Mar;49(4):811-20. doi: 10.1016/0002-9149(82)91963-4. No abstract available.
PubMed 7039286Rizza RA, Mandarino LJ, Gerich JE. Dose-response characteristics for effects of insulin on production and utilization of glucose in man. Am J Physiol. 1981 Jun;240(6):E630-9. doi: 10.1152/ajpendo.1981.240.6.E630.
PubMed 7018254Cohen P, Barzilai N, Barzilai D, Karnieli E. Correlation between insulin clearance and insulin responsiveness: studies in normal, obese, hyperthyroid, and Cushing's syndrome patients. Metabolism. 1986 Aug;35(8):744-9. doi: 10.1016/0026-0495(86)90242-8.
PubMed 3526086
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Insulin Effects on Cardiac Function in Patients With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02962921
- Acronym / sponsor ID
- 1558-RMB-CTIL
- Conditions
- Diabetes Mellitus, Ventricular Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Feb 2003
- Primary completion
- May 2003 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 15 Nov 2016 (estimated)
- 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.
Our investigation studies the role of acute insulin administration on the diabetic heart, its corresponding effective blood-insulin level and the time-course applicability of insulin in a routine clinical setting.
A case series of six male (48.1 ± 4.9 y/o) patients with controlled diabetes (HbA1c of 6.6 ± 0.3%, disease duration of 14.4 ± 6.7 yr). Each subject was evaluated for glucose homeostatic, hemodynamic and echocardiographic systolic and diastolic parameters at baseline and following two successive insulin-load steps of a euglycemic hyperinsulinemic clamp study, each 2 h in duration. Results are presented as a mean ± SEM and analysed using the student's t-test.
Detailed description
Patients:
Six male diabetic (five type 2 and one type 1) patients, 30-65 year old, with an established diagnosis of diabetes mellitus for ≥2 years, who were free of significant valvular heart disease, atrial arrhythmia or cardiac pacing comprised the study population. Patients' characteristics are summarized in table 1.
Each patient served as his or her own control. The study protocol was approved by the ethics committee at Rambam Medical Center, Haifa, Israel. Prior to the study, patients gave written informed consent after receiving a detailed explanation as to the purpose of the study, the technique, its side effects and the study protocol.
Patients were studied within a clinical research facility at the Rambam Medical Center, Haifa, Israel. Baseline evaluation was conducted at 8:00 am after 12 h of fasting, followed by two hyperinsulinemic euglycemic clamp (EHC) steps (2 h each step); The following vital signs were monitored during the study protocol: manual heart rate, systolic blood pressure (SBP), diastolic blood pressure (DBP) and baseline 12-lead electrocardiogram (ECG) recording. Glucose consumption rates against changing insulin levels were measured by the EHC technique. Cardiac function parameters were measured in the last 10 min of each step by tissue Doppler echocardiography. Results are presented as a mean ± SEM.
Clamp technique:
Each patient underwent an EHC study according to the protocol described previously, and implemented in our institute. Baseline measurements of blood insulin and glucose levels were collected. Thereafter, two insulin loads were initiated. The blood glucose level was kept near euglycemia (90 ± 5 mg/dl) throughout 2 h period of each insulin load step. Intravenous (iv) insulin loads were administered by 1- and 10-mU/kg·min at steps 1 and 2 of insulin loading (Lispro Insulin, Eli Lilly, France), respectively. Dexstrose in water 50% (DW50) was infused at variable infusion rates, titrated to maintain euglycemia. Concomitant saline 0.45% was used to dilute the DW50 in order to prevent hypertonicity-induced irritation of the cannuled vein. During the baseline period, saline 0.45% infusion rates were 0.75 ml/min to keep the iv cannule open. Every patient was given a chance to urinate before step 2.
Glucose and insulin homeostatic parameters of the study group were compared to those of healthy controls we studied earlier.
Cardiac function assessment:
Transthoracic echocardiography was performed by a qualified echocardiographer using a General Electric Vivid 3 machine (Tirat HaCarmel, Israel). Parameters were assessed as the mean of three consecutive heart beats.
Systolic echocardiographic parameters:
LV fractional shortening (LVFS) derived from end diastolic and end systolic LV dimensions; LV ejection fraction (LVEF) derived from end diastolic and end systolic LV volumes.
Diastolic echocardiographic parameters:
- Mitral valve diastolic flow parameters by pulse wave Doppler: E wave, represents early diastolic filling; A wave, represents late diastolic filling concomitant with the atrial kick, E/A ratio and E wave deceleration time (DT).
- Tissue Doppler-derived velocities of the mitral annulus: E' represents early diastolic velocity synchronous to the mitral inflow E wave, measured close to the interventricular septum (E' medial) and lateral wall (E' lateral); E' mean, derived from E' lateral and E' medial. A' represents late diastolic velocity to the synchronous mitral inflow A wave, measured close to the septum (A' medial) and lateral wall (A' lateral). A' mean is derived from A' lat. and A' med. A' reflects mitral annulus movement during atrial contraction. The E to E' ratio represents diastolic LV compliance.
Results are presented as mean ± SEM and analyzed using the student's t-test. Statistical significance considered when p value less than 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients | Experimental | Drug: Insulin LISPRO intravenous loadingDiabetic patients were treated with insulin loads, left ventricle functional parameters were compared to those of healthy persons. Metabolic indices of insulin effect: blood insulin levels, glucose disposal rates under insulin infusion, were compared to respective group of healthy persons, studied earlier at our institution Insulin LISPRO intravenous loading |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diabetes mellitus duration of 2 years and over.
Key exclusion criteria (1 listed)
- Previous cardiac disease: valvular, Pacing, Arrhythmias, Primary Cardiomyopathy.
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 |
|---|---|---|
| Insulin LISPRO intravenous loadingAlso: Humalog Insulinintravenous infusion of insulin Lispro. | Drug | Diabetic patients |
Primary outcome
Left ventricle ejection fraction (%)
Time frame: 1 year
1 secondary outcome
Time needed to exert insulin effect on myocardial function (hour)
Time frame: 1 year
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 15 Nov 2016.
- Results publication: PubMed 15362503Adeghate E. Molecular and cellular basis of the aetiology and management of diabetic cardiomyopathy: a short review. Mol Cell Biochem. 2004 Jun;261(1-2):187-91. doi: 10.1023/b:mcbi.0000028755.86521.11.
- Results publication: PubMed 11179253Francis GS. Diabetic cardiomyopathy: fact or fiction? Heart. 2001 Mar;85(3):247-8. doi: 10.1136/heart.85.3.247. No abstract available.
- Results publication: PubMed 11179524Kitzman DW, Gardin JM, Gottdiener JS, Arnold A, Boineau R, Aurigemma G, Marino EK, Lyles M, Cushman M, Enright PL; Cardiovascular Health Study Research Group. Importance of heart failure with preserved systolic function in patients > or = 65 years of age. CHS Research Group. Cardiovascular Health Study. Am J Cardiol. 2001 Feb 15;87(4):413-9. doi: 10.1016/s0002-9149(00)01393-x.
- Results publication: PubMed 15202695Gutierrez C, Blanchard DG. Diastolic heart failure: challenges of diagnosis and treatment. Am Fam Physician. 2004 Jun 1;69(11):2609-16.
- Results publication: PubMed 10768918McMurray JJ, Stewart S. Epidemiology, aetiology, and prognosis of heart failure. Heart. 2000 May;83(5):596-602. doi: 10.1136/heart.83.5.596. No abstract available.
- Results publication: PubMed 4263660Rubler S, Dlugash J, Yuceoglu YZ, Kumral T, Branwood AW, Grishman A. New type of cardiomyopathy associated with diabetic glomerulosclerosis. Am J Cardiol. 1972 Nov 8;30(6):595-602. doi: 10.1016/0002-9149(72)90595-4. No abstract available.
- Results publication: PubMed 16543510Poornima IG, Parikh P, Shannon RP. Diabetic cardiomyopathy: the search for a unifying hypothesis. Circ Res. 2006 Mar 17;98(5):596-605. doi: 10.1161/01.RES.0000207406.94146.c2.
- Results publication: PubMed 7030513Fein FS, Strobeck JE, Malhotra A, Scheuer J, Sonnenblick EH. Reversibility of diabetic cardiomyopathy with insulin in rats. Circ Res. 1981 Dec;49(6):1251-61. doi: 10.1161/01.res.49.6.1251.
- Results publication: PubMed 1414944Hiramatsu K, Ohara N, Shigematsu S, Aizawa T, Ishihara F, Niwa A, Yamada T, Naka M, Momose A, Yoshizawa K. Left ventricular filling abnormalities in non-insulin-dependent diabetes mellitus and improvement by a short-term glycemic control. Am J Cardiol. 1992 Nov 1;70(13):1185-9. doi: 10.1016/0002-9149(92)90053-2.
- Results publication: PubMed 21864757Iliadis F, Kadoglou N, Didangelos T. Insulin and the heart. Diabetes Res Clin Pract. 2011 Aug;93 Suppl 1:S86-91. doi: 10.1016/S0168-8227(11)70019-5.
- Results publication: PubMed 2215248Cohen P, Harel C, Bergman R, Daoud D, Pam Z, Barzilai N, Armoni M, Karnieli E. Insulin resistance and acanthosis nigricans: evidence for a postbinding defect in vivo. Metabolism. 1990 Oct;39(10):1006-11. doi: 10.1016/0026-0495(90)90158-9.
- Results publication: PubMed 382871DeFronzo RA, Tobin JD, Andres R. Glucose clamp technique: a method for quantifying insulin secretion and resistance. Am J Physiol. 1979 Sep;237(3):E214-23. doi: 10.1152/ajpendo.1979.237.3.E214.
- Individual participant dataSharing planned: Undecided. First we need to learn how to share data
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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.
Eddy Karnieli, MD study chair
Professor emeritus, Faculty of medicine, Technion. Haifa, Israel
Ronen Bar Yoseph, MD principal investigator
Pediatric Pulmonary Institute
Sergey Yalonetsky, MD principal investigator
Cardiology Division
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 Insulin LISPRO intravenous loading in people with Diabetes Mellitus and Ventricular Dysfunction, run by Rambam Health Care Campus at 1 site in Israel.
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 1 inclusion and 1 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 15 Nov 2016. 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 Israel. 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.
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?
Left ventricle ejection fraction (%) (time frame: 1 year). 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 NCT02962921, which also lists 24 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 15 Nov 2016.