An observational study in Dilated Cardiomyopathy, Thrombosis and Stroke, sponsored by Hospital General Universitario Gregorio Marañon. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-25.
Sponsored by Hospital General Universitario Gregorio Marañon · Observational
Among 20 studies in Cardiomyopathy, Dilated with a site in Spain — 6 open to participants now, 9 under way, 3 of them phase 3. Cardiomyopathy, Dilated · Spain.
Among the 20 studies in Cardiomyopathy, Dilated with a site in Spain, this one is one of 2 that started in 2018, is one of 7 observational ones, and was the 8th registered.
255 studies on the registry are indexed under Cardiomyopathy, Dilated; 66 are open to participants now.
Browse Cardiomyopathy, Dilated studies →6 of the 20 studies in Cardiomyopathy, Dilated with a site in Spain are open now. Recruiting first, the newest first:
Kardigan, Inc. · Sites in Spain, United States, Belgium and 8 more countries
Ages 18+
Kardigan, Inc. · Sites in Spain, United States, Belgium and 8 more countries
Ages 18+
Alexion Pharmaceuticals, Inc. · Sites in Spain, United States, Italy and 1 more country
Ages 18–70
Centro Medico Teknon · Sites in Spain, Italy, Portugal
Ages 18+
Consorcio Centro de Investigación Biomédica en Red (CIBER) · Sites in Spain
Ages 18+
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 53 Cardiomyopathy, Dilated studies recruiting now, 30 (57%) set no upper age limit and 15 (28%) stop at 75 or younger; 13 take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 6 · Phase 3 5 · Phase 4 1
First in 2008; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 80 is below the median of 245 across 96 observational studies indexed under Cardiomyopathy, Dilated.
Median enrollment 70 across the 13 interventional studies, 200 across the 7 observational. Of the 9 that completed or were terminated, 2 (22%) have results posted.
This tab as a report to print or save as PDF → With an account.
7 of 20 have an industry lead sponsor. The 10 most frequent:
Hospital General Universitario Gregorio Marañon is the lead sponsor of 60 studies on the registry; 7 are open to participants now.
Hospital General Universitario Gregorio Marañon has 3 studies filed under Cardiomyopathy, Dilated — fewer than ten, so there is no comparison to draw.
2 of the studies in Cardiomyopathy, Dilated with a site in Spain that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07210723Phase 3Kardigan, Inc.A Study of the Efficacy and Safety of Danicamtiv in Participants With Symptomatic Genetic and Familial Dilated Cardiomyopathy | 2027-09 |
| NCT05981092Alexion Pharmaceuticals, Inc.A Study About the Natural History in Adults With BAG3 Dilated Cardiomyopathy (a Type of Heart Disease) (BAG3 DCM) | 2027-08-12 |
Add all 2 to your calendar (.ics) → With an account.
Among the 20 studies in Cardiomyopathy, Dilated with a site in Spain, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This study is designed to quantify the ventricular stasis in patients with non-ischemic dilated cardiomyopathy by post-processing of 2D color Doppler echocardiography images in order to establish the relationship between quantitative variables of intraventricular stasis and the prevalence of silent embolic events and/or intraventricular mural thrombosis determined by magnetic resonance.
In patients with left ventricular dysfunction, intraventricular mural thrombosis is a recognized risk factor for cardioembolic events. The flow stasis accompanying ventricular remodeling and myocardial dysfunction could favor the formation of small intracavitary thrombi between LV trabeculae, small enough not be detected by conventional imaging techniques. Computational post-processing techniques allow a robust and complete characterization of numerous aspects of fluid dynamics within the heart using the flow field obtained by Echo or MRI imaging, and it is possible to quantify the stasis and washing of blood in the left ventricular cavity.
A cross-sectional study in 80 patients with non-ischemic DCM in sinus rhythm is proposed in which an echocardiogram, cardiac and cerebral MRI will be performed. Our objective is to quantify the ventricular stasis by post-processing of 2D color Doppler echocardiography images in order to establish the relationship between quantifiable intraventricular stasis variables and the prevalence of silent and embolic events and intracavitary thrombosis determined by magnetic resonance (MRI).
80 patients with diagnosis of non-ischemic dilated cardiomyopathy under follow-up in the Cardiology Department of Gregorio Marañón General University Hospital, Madrid, who meet all of the inclusion criteria and none of the exclusion criteria will be included.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A cohort of 80 patients with nonischemic dilated cardiomyopathy in sinus rhythm with left ventricle ejection fraction (EF) less than 45%. In the first 24 hours after enrollment a coagulation blood test, an electrocardiogram, a Doppler echocardiogram exam and a clinical examination (including neuropsiquiatric evaluation) will be performed. A cardiac magnetic resonance and a brain magnetic resonance will be performed within 10 days after the enrollment.
Diagnostic Test: Doppler echocardiogram exam · Diagnostic Test: Cardiac Magnetic Resonance · Diagnostic Test: Brain Magnetic Resonance · Diagnostic Test: Coagulation blood test
A complete echocardiographic study will be performed at enrollment. The echocardiographic images will be acquired as clinically recommended. The protocol will include the acquisition of 1) 2D images in parasternal axis long and short axis; 2) 2D and Doppler tissue images in the apical planes of 4, 2 and 3 chambers; 3) Pulsed, continuous and color Doppler M (DCMM) of transmitral LV flow and LV ejection; 4) 3-Chamber apical plane with and without color Doppler; and 5) 3D LV images. DCMM images will be obtained from the apical window using 4 and 5 chamber planes. Blood flow velocity will be obtained using Color and Gray mode in the 3 chamber view during 5-10 beats in apnea.
A cardiac MR will be acquired within 10 days after the enrollment. The protocol includes the following sequences: cine mode of short axis from LV base to apex and 2-3-4 chambers. 3D sequence of late enhancement of inversion-recovery. Images will be acquired after 3 min and 10 min of the administration of a total of 0.2 mmol / kg of Prohance®. Intraventricular thrombosis will be monitored. Phase contrast sequences in three orthogonal planes will be acquired. Morphological parameters of LV function (LVEF), contractility ("Wall Motion Score ") and sphericity index will be measured.
A brain MR will be acquired within 10 days after the enrollment. Axial, sagittal and coronal spin echo sequence in T1, axial images in diffusion sequences (DWI), enhanced spin echo T2 and FLAIR (fluid-attenuated inversion recovery) sequences shall be obtained. A cerebral infarction will be positive when finding the presence of a focal lesion of\> 3 mm in diameter that meets one of these three characteristics: (1) high signal on isotropic DWI images and low signal on the apparent coefficient map Broadcast (ADC). (2) Cavitary lesion hyperintense on T2, with no signal (or low) in the FLAIR sequence. (3) Hyperintense lesion T2 / T1 hypointense with prior distribution defect known or new in a follow-up study.
5 ml of peripheral blood will be obtained for assessment of prothrombotic markers at enrollment.
Prevalence of the combined binary variable consisting of left ventricular mural thrombosis or silent brain infarct detected by magnetic resonance imaging
Quantification of the prevalence of the combined binary variable consisting of one of the following: ventricular thrombosis assessed by cardiac magnetic resonance or silent brain infarct detected by brain magnetic resonance.
Time frame: Within 10 days after enrollment
Left ventricle mural thrombosis assessed by cardiac magnetic resonance imaging
Left ventricle mural thrombosis will be assessed by contrast cardiac MRI. Early after gadolinium contrast administration (3 min), two dimensional T1-weighted fast-field-echo sequences with an inversion-recovery prepulse will be used. A long inversion time (520 ms) will be used to identify intraventricular thrombus as a LV mass with low-signal intensity surrounded by high-signal intensity structures.
Time frame: Within 10 days after enrollment
Silent brain infarcts (SBI)
SBIs diagnosis entails the presence of a focal lesion \> 3 mm that meets one of the three following criteria: 1) high signal on DWI isotropic images and low signal on the map of apparent diffusion coefficient (ADC). DWI sequence allows to detecting ischemic lesions (4 hours) and assessing their chronology. (2) cavitary lesion hyperintense on T2, with no signal (or low) in the FLAIR sequence usually surrounded by a ring gliotic hyperintense, hypointense on T1). (3) hyperintense lesion on T2 / T1 hypointense with prior distribution defect known or new in a follow-up study. The studies will be interpreted by a neuroradiologist blinded to clinical and echocardiographic information. For the assessment of whether the brain infarct is clinically silent, a medical history and physical examination focused on neurological symptoms will be performed including for that purpose the National Institute of Health (USA) questionnaire.
Time frame: Within 10 days after enrollment
Cognitive impact of SBIs
Cognitive impact of SBIs assessed by MMSE. The Mini Mental State Examination (MMSE) is a tool that can be used to systematically and thoroughly assess mental status. It is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The maximum score is 30, and the minimum score is 0. A score of 23 or lower is indicative of cognitive impairment. The following three cut-off levels are employed to classify the severity of cognitive impairment: no cognitive impairment = 24-30; mild cognitive impairment = 18-23; severe cognitive impairment = 0-17.
Time frame: Within 10 days after enrollment
Neuropsychiatric impact of SBIs
Neuropsychiatric impact of SBIs assessed by the Beck Depression Inventory. The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression; each set is ranked in terms of severity and scored from 0 to 3. The maximun score for the whole test is 63 and the lowest is 0. The cut-off scores with patients diagnosed as having an affective disorder are the following: none or minimal depression is \< 10; mild to moderate depression is 10-18; moderate to severe depression is 19-29; and severe depression is 30-63.
Time frame: Within 10 days after enrollment
Plan to share: Undecided
Ran from Feb 2018 to primary completion in Nov 2020, 33 months.
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Hospital General Universitario Gregorio Marañon